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
94081–94104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 21, 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
K963057 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 227d
Cleared Mar 21, 1997
METAGEN ALL POLY ACETABULAR CUP SYSTEM
K964003 · JDI
Metagen, LLC
Orthopedic · 165d
Cleared Mar 21, 1997
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)
K964167 · IYE
Multidata Systems International Corp.
Radiology · 156d
Cleared Mar 21, 1997
ELLIPSE 4
K964522 · FEN
Andromeda Medizinische Systeme GmbH
Gastroenterology & Urology · 129d
Cleared Mar 21, 1997
LIBERTY VALVE
K964690 · KNX
Cleveland Medical Devices, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 21, 1997
ALLCLENZ WOUND CLEANSER
K965120 · KMF
Dpt Laboratories, Ltd.
General & Plastic Surgery · 88d
Cleared Mar 21, 1997
TRUFILL PVA PARTICLES
K965174 · HCG
Cordis Neurovascular, Inc.
Neurology · 87d
Cleared Mar 21, 1997
CES INFUSION CATHETER
K965181 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 87d
Cleared Mar 21, 1997
THERMAPREP PLUS OVEN
K970134 · EKM
Tulsa Dental Products, Ltd.
Dental · 65d