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
94585–94608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1997
AVANTA ORTHOPAEDICS TENDON SPACER
K964359 · HXA
Avanta Orthopaedics, Inc.
Orthopedic · 144d
Cleared Mar 25, 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · JDI
Corin USA
Orthopedic · 99d
Cleared Mar 25, 1997
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
K970019 · LPL
Menicon U.S.A., Inc.
Ophthalmic · 82d
Cleared Mar 25, 1997
FIXATION PIN OR ROD
K970036 · HTY
United States Surgical, A Division of...
Orthopedic · 81d
Cleared Mar 25, 1997
EXTRACTORRX
K970052 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Mar 25, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
K970089 · MBI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Mar 25, 1997
HEDGES CORNEAL WETTING PAK
K970161 · KYG
Hedges Cwp, Inc.
Ophthalmic · 70d
Cleared Mar 25, 1997
IRRIGATION/ASPIRATION POLYPECTOMY
K970356 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared Mar 25, 1997
VICTORY EYEWEAR CO
K970538 · HQY
Victory Eyewear Co., Ltd.
Ophthalmic · 41d
Cleared Mar 25, 1997
CORE AND COIL ASSEMBLY GUIDEWIRE
K970994 · EZB
Lake Region Mfg., Inc.
Gastroenterology & Urology · 6d
Cleared Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · LFZ
Abbott Laboratories
Microbiology · 579d
Cleared Mar 24, 1997
TOXO IGG ELISA TEST
K962343 · LGD
Gull Laboratories, Inc.
Microbiology · 279d
Cleared Mar 24, 1997
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
K963587 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Mar 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
K964257 · LKL
Beckman Instruments, Inc.
Immunology · 150d
Cleared Mar 24, 1997
ELECSYS PROGESTERONE ASSAY
K964841 · JLS
Boehringer Mannheim Corp.
Chemistry · 111d
Cleared Mar 24, 1997
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND...
K964844 · FPA
Conmedcorp
General Hospital · 111d
Cleared Mar 24, 1997
AXSYM B12
K965186 · CDD
Abbott Laboratories
Chemistry · 90d
Cleared Mar 24, 1997
SPINNAKER
K965189 · KRA
Target Therapeutics
Cardiovascular · 90d
Cleared Mar 24, 1997
JELENKO NO.1 (CODE NAME RD-0601)
K970068 · EJT
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Mar 24, 1997
BILE ACIDS REAGENT SET
K970120 · KWW
Teco Diagnostics
Chemistry · 69d
Cleared Mar 24, 1997
CHIRON DIAGNOSTICS ACS:180TU P
K970539 · KHQ
Chiron Diagnostics Corp.
Chemistry · 40d
Cleared Mar 24, 1997
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA...
K970597 · JSM
Medical Packaging Corp.
Microbiology · 34d
Cleared Mar 21, 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K962010 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 302d
Cleared Mar 21, 1997
KREATIV KURING LIGHT SYSTEM
K962376 · EBF
Kreativ, Inc.
Dental · 274d