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
92089–92112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1997
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · LHI
Baxter Healthcare Corp
General Hospital · 29d
Cleared Oct 23, 1997
BARIAIR
K955243 · FNM
Kinetic Concepts, Inc.
General Hospital · 708d
Cleared Oct 23, 1997
EDEMA SYSTEM
K962783 · DSB
Bioanalogics, Inc.
Cardiovascular · 463d
Cleared Oct 23, 1997
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · DRF
C.R. Bard, Inc.
Cardiovascular · 202d
Cleared Oct 23, 1997
MCD-AC
K971980 · KPS
Adac Laboratories
Radiology · 147d
Cleared Oct 23, 1997
BANG POLYMER GEL DOSIMETER, BANG 533
K972804 · IYE
Mgs Research, Inc.
Radiology · 87d
Cleared Oct 22, 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 236d
Cleared Oct 22, 1997
AHCS HEMOPERFUSION SYSTEM
K971015 · FLD
American Health Care Systems, Inc.
Gastroenterology & Urology · 216d
Cleared Oct 22, 1997
MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS...
K971420 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 188d
Cleared Oct 22, 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
K971683 · MSX
Marquette Electronics, Inc.
Cardiovascular · 168d
Cleared Oct 22, 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · LGD
Bayer Corp.
Microbiology · 146d
Cleared Oct 22, 1997
FINALLY FREE
K972695 · KCX
Mehl/Group Marketing
General & Plastic Surgery · 96d
Cleared Oct 22, 1997
LINK, ACETABULAR REVISION MESH CUP
K972760 · JDJ
Link America, Inc.
Orthopedic · 90d
Cleared Oct 22, 1997
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K972836 · LTZ
G. Premjee (Usa), Inc.
Obstetrics & Gynecology · 83d
Cleared Oct 22, 1997
MDP2000 MEDICAL DATA PROCESSOR
K972880 · MSX
Vidco, Inc.
Cardiovascular · 78d
Cleared Oct 22, 1997
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · MGP
Innovative Technologies , Ltd.
General & Plastic Surgery · 49d
Cleared Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN...
K973331 · DBF
Ortho-Clinical Diagnostics, Inc.
Immunology · 48d
Cleared Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · DHR
Instrumentation Laboratory CO
Immunology · 40d
Cleared Oct 22, 1997
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588 · CJE
Pointe Scientific, Inc.,
Chemistry · 30d
Cleared Oct 21, 1997
FEMASSIST URINARY DEVICE
K963858 · MNG
Insight Medical Corp.
Gastroenterology & Urology · 391d
Cleared Oct 21, 1997
HISTOFREEZER VERRUCA PLANA
K971392 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 189d
Cleared Oct 21, 1997
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND...
K971436 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 186d
Cleared Oct 21, 1997
SERAQUEST TOXOPLASMA IGM
K971672 · LGD
Quest Intl., Inc.
Microbiology · 167d
Cleared Oct 21, 1997
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
K971897 · LFK
Medron, Inc.
Gastroenterology & Urology · 152d