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
114577–114600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1993
AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS
K924725 · MDM
American Biomaterials Corp.
General & Plastic Surgery · 137d
Cleared Feb 05, 1993
AUTOVAC 7900 SERIES
K924894 · CAC
Boehringer Laboratories
Anesthesiology · 130d
Cleared Feb 05, 1993
TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP
K925181 · JDL
Techmedica, Inc.
Orthopedic · 114d
Cleared Feb 05, 1993
ABBOTT QUICKSTART LD-1, MODIFICATION
K925188 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 05, 1993
THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
K925194 · JZO
Joldon Diagnostics
Immunology · 113d
Cleared Feb 05, 1993
OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
K925339 · CKA
Olympus Corp.
Chemistry · 108d
Cleared Feb 05, 1993
ELECTROMEDICS TISSUE TRAP/ #TT280
K925412 · BYZ
Electromedics, Inc.
General Hospital · 102d
Cleared Feb 05, 1993
BIOVATION K-MANAGER
K925528 · GKZ
Biovation, Inc.
Hematology · 95d
Cleared Feb 05, 1993
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K925626 · DTZ
Medtronic Vascular
Cardiovascular · 91d
Cleared Feb 05, 1993
SPUNCRIT
K925863 · GKG
bioMerieux, Inc.
Hematology · 78d
Cleared Feb 05, 1993
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
K925880 · JJX
Eastman Kodak Company
Chemistry · 78d
Cleared Feb 05, 1993
FOOT CONTROL PENCIL
K926306 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 52d
Cleared Feb 04, 1993
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
K923860 · GWQ
Biosound, Inc.
Neurology · 188d
Cleared Feb 04, 1993
SURGICO OXYGEN MASK
K924069 · BYG
Gujarat Surgico, Ltd.
Anesthesiology · 177d
Cleared Feb 04, 1993
PAP ANTIBODY KIT
K924629 · DFD
Ventana Medical Systems, Inc.
Immunology · 143d
Cleared Feb 03, 1993
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
K913474 · BTM
Med-Tek Innovations, Inc.
Anesthesiology · 548d
Cleared Feb 03, 1993
MODEL 5002 LIFT WEIGH-SCALE
K922119 · FRW
Acme Medical Scale Co.
General Hospital · 274d
Cleared Feb 03, 1993
PERIFLUX PF4001 LASER DOPPLER FLOWMETER
K922368 · DPW
Perimed, Inc.
Cardiovascular · 259d
Cleared Feb 03, 1993
CORDIS VIERA GUIDEWIRE
K923696 · DQX
Cordis Corp.
Cardiovascular · 195d
Cleared Feb 03, 1993
BAC-T-SCREEN
K924218 · JXA
Biomerieux Vitek, Inc.
Microbiology · 167d
Cleared Feb 03, 1993
DERMASSIST TRANSPARENT SITE DRESSING
K924249 · KMK
Wilshire Medical Products
General Hospital · 163d
Cleared Feb 03, 1993
BIOMERIEUX HEMOLAB THROMBOMAT
K925492 · GJS
Biomerieux Vitek, Inc.
Hematology · 93d
Cleared Feb 03, 1993
THE MILLER NEBULIZER SYSTEM
K926055 · CAF
Warren C. Miller
Anesthesiology · 90d
Cleared Feb 03, 1993
REFLAB SYSTEM PACK LIQUID CO2 REAGENT
K926320 · CHS
Medical Analysis Systems, Inc.
Chemistry · 50d