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Browse 517 FDA-cleared medical devices

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517 devices

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533)

Class Class II K243533 FMK
2025-01-13

SpectoMed (v1.0) (K242205)

Class Class II K242205 LLZ
2025-01-14

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (K242416)

Class Class II K242416 EOQ
2025-01-16

Second Opinion CC (K242522)

Class Class II K242522 MYN
2025-01-16

System 9 Sterile Battery Container (K242834)

Class Class II K242834 KCT
2025-01-16

Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (K242705)

Class Class II K242705 LDF
2025-01-17

Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (K241443)

Class Class II K241443 NUC
2025-01-21

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) (K241956)

Class Class II K241956 FGB
2025-01-22

Suture-TOOL System (K242835)

Class Class II K242835 NEW
2025-01-22

Symani Surgical System (820-03830) (K250014)

Class Class II K250014 SAQ
2025-01-27
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