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
73513–73536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2002
EBI XFIX DFS SYSTEM
K023399 · KTT
Ebi, L.P.
Orthopedic · 16d
Cleared Oct 25, 2002
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
K023420 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 14d
Cleared Oct 25, 2002
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
K023428 · LZA
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 14d
Cleared Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
K020831 · GJS
Roche Diagnostics Corp.
Hematology · 224d
Cleared Oct 24, 2002
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD...
K021250 · EBF
Handpiece Unlimited
Dental · 188d
Cleared Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
K021595 · ETN
Gyrus Ent LLC
Ear, Nose, Throat · 162d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K021689 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 154d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
K021690 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K021693 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
INRATIO SELF-TEST
K021923 · GJS
Hemosense, Inc.
Hematology · 135d
Cleared Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217 · EIA
Aseptico, Inc.
Dental · 108d
Cleared Oct 24, 2002
CARDIO ID+(RZ153+)
K022540 · DSH
Rozinn Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
K022741 · MUJ
Nucletron Corporation
Radiology · 66d
Cleared Oct 24, 2002
CLEARFIL AP-X PLT INTRO KIT
K022999 · EBF
Kuraray Medical, Inc.
Dental · 45d
Cleared Oct 24, 2002
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
K023058 · KXT
Seradyn
Toxicology · 41d
Cleared Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · JIX
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Oct 24, 2002
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA...
K023182 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Oct 24, 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · MKW
Microgenics Corp.
Chemistry · 29d
Cleared Oct 24, 2002
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
K023223 · DQY
Lumend, Inc.
Cardiovascular · 27d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 8d
Cleared Oct 23, 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285 · GWM
Cma Microdialysis AB
Neurology · 268d
Cleared Oct 23, 2002
MICROSCAN SYNERGIES PLUS
K023202 · JWY
Dade Microscan, Inc.
Microbiology · 28d