FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

119329–119352 of 174,955

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Oct 23, 1991

VASCULAR GUIDE WIRE

Advanced Cardiovascular Systems, Inc.

Cardiovascular · 89d

Cleared Oct 23, 1991

CIRRUS GAMMA CAMERA

Adac Laboratories

Radiology · 79d

Cleared Oct 23, 1991

MOBILE X-RAY SYSTEM

Siemens Medical Solutions USA, Inc.

Radiology · 76d

Cleared Oct 23, 1991

JTECH 50 SERIES CUTTING LOOP

Gastroenterology & Urology · 72d

Cleared Oct 23, 1991

MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM

Siemens Gammasonics, Inc.

Radiology · 69d

Cleared Oct 23, 1991

BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER

Augustine Medical, Inc.

Cardiovascular · 64d

Cleared Oct 23, 1991

BODAI NEO2 -SAFE AIRWAY PRESSURE CAP

B&B Medical Technologies, Inc.

Anesthesiology · 63d

Cleared Oct 23, 1991

ANOMALOSCOPE QUADRANT TEST-6

Lkc Technologies, Inc.

Ophthalmic · 48d

Cleared Oct 23, 1991

MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS

Marlo Surgical Technology

General & Plastic Surgery · 48d

Cleared Oct 23, 1991

MULTIPLE LATEX PATIENT EXAMINATION GLOVES

London Rubber Co. (India) , Ltd.

General Hospital · 43d

Cleared Oct 23, 1991

BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE

Bivona Medical Technologies

Anesthesiology · 42d

Cleared Oct 23, 1991

CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER

Cardiovascular · 37d

Cleared Oct 23, 1991

BIVONA CUFF MAINTENANCE DEVICE (CMD)

Bivona Medical Technologies

Anesthesiology · 35d

Cleared Oct 23, 1991

CLEARSITE(R) STERILE WOUND CARE DRESSING

Ndm Acquisition Corp.

General & Plastic Surgery · 34d

Cleared Oct 23, 1991

FORTEX(TM) WOUND DRESSING

Calgon Vestal Div.

General & Plastic Surgery · 27d

Cleared Oct 23, 1991

PIT AND FISSURE SEALANT PRODUCTS

Confi-Dental Products Co.

Cleared Oct 23, 1991

BARITONE C2 & BARITONE L3

Confi-Dental Products Co.

Cleared Oct 23, 1991

DEXON DISSECTING SPONGE

Davis & Geck, Inc.

General & Plastic Surgery · 22d

Cleared Oct 23, 1991

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL

Johnson & Johnson Orthopaedics, Inc.

Orthopedic · 19d

Cleared Oct 23, 1991

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

Serono-Baker Diagnostics, Inc.

Chemistry · 16d

Cleared Oct 21, 1991

LYME STAT M TEST KIT

Whittaker Bioproducts, Inc.

Microbiology · 371d

Cleared Oct 21, 1991

Orion Diagnostica, Inc.

Microbiology · 374d

Cleared Oct 21, 1991

ATRAUMATIC STANDARD SPROTTE NEEDLE

Anesthesiology · 213d

Cleared Oct 21, 1991

Implant Innovations International, Inc.