FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93865–93888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT,...
K971333 · JIX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared May 23, 1997
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
K971415 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 36d
Cleared May 23, 1997
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K971423 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 36d
Cleared May 23, 1997
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
K971584 · OCV
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 23, 1997
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
K971658 · DBL
Jay H. Geller
Immunology · 39d
Cleared May 22, 1997
VECTORVISION
K962939 · HAW
Brainlab, Inc.
Neurology · 297d
Cleared May 22, 1997
BIO-ANCHOR
K963369 · MAI
Linvatec Corp.
Orthopedic · 268d
Cleared May 22, 1997
OSMOCYTE WOUND MANAGER SHEET DRESSING
K965143 · MGQ
Procyte Corp.
General & Plastic Surgery · 150d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF...
K970257 · HSB
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE...
K970258 · HRS
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF...
K970280 · HSB
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
3-CCD DIGITAL CAMERA
K970605 · GCJ
Envision Medical Corp.
General & Plastic Surgery · 93d
Cleared May 22, 1997
CRYSTAL-EEG MODEL 10 (MODEL 10)
K970672 · OMC
Cleveland Medical Devices, Inc.
Neurology · 87d
Cleared May 22, 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
K970705 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
K970706 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758 · JWH
Howmedica Corp.
Orthopedic · 80d
Cleared May 22, 1997
INSTRUMENT HOLDER
K970900 · GCJ
Contour Fabricators, Inc.
General & Plastic Surgery · 72d
Cleared May 22, 1997
DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE
K970993 · GEI
Deroyal Industries, Inc.
General & Plastic Surgery · 64d
Cleared May 22, 1997
NEO-CARE LUMBER PUNCTURE KIT
K970997 · MIA
Klein-Baker Medical, Inc.
Anesthesiology · 64d
Cleared May 22, 1997
AYURVEDIC TONGUE CLEANER
K971025 · LCN
Calello Martinez P.C.
Dental · 63d
Cleared May 22, 1997
MEMOREG
K971155 · ELW
Heraeus Kulzer, Inc.
Dental · 55d
Cleared May 22, 1997
ML DISPOSABLE ALK TUBING
K971173 · KYG
Med-Logics, Inc.
Ophthalmic · 52d
Cleared May 22, 1997
DSL ACTIVE T4 EIA
K971269 · KLI
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 22, 1997
DSL ACTIVE T3 EIA
K971270 · CDP
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d