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
86449–86472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1999
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K984558 · KGO
Ansell Perry
General Hospital · 65d
Cleared Feb 26, 1999
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K984559 · KGO
Ansell Perry
General Hospital · 65d
Cleared Feb 26, 1999
DIOSCAN
K990014 · GEX
Diomed, Inc.
General & Plastic Surgery · 53d
Cleared Feb 26, 1999
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
K990106 · MKJ
Bio-Detek, Inc.
Cardiovascular · 45d
Cleared Feb 26, 1999
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
K990222 · DHA
Diagnostic Products Corp.
Chemistry · 32d
Cleared Feb 26, 1999
CROSS SPORT, RIGID WHEELCHAIR
K990358 · IOR
Tisport
Physical Medicine · 21d
Cleared Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544,...
K990377 · DIF
Roche Diagnostics Corp.
Toxicology · 18d
Cleared Feb 26, 1999
ARTHRO-SURGIMAT-2000 ECU
K990443 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 15d
Cleared Feb 25, 1999
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
K983110 · LNH
Toshiba America Mri, Inc.
Radiology · 174d
Cleared Feb 25, 1999
HYBRISONIC SHEATH
K983985 · ITX
Sonotech, Inc.
Radiology · 108d
Cleared Feb 25, 1999
ELIPAR TRILIGHT
K984247 · EBZ
Espe Dental AG
Dental · 90d
Cleared Feb 25, 1999
GC UNIFAST TRAD
K984365 · EBI
GC America, Inc.
Dental · 80d
Cleared Feb 25, 1999
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000)...
K984545 · IZI
Philips Medical Systems North...
Radiology · 65d
Cleared Feb 25, 1999
GLUMA ONE BOND
K990143 · KLE
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Feb 25, 1999
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
K990155 · EMA
Kay See Dental Mfg. Co.
Dental · 37d
Cleared Feb 25, 1999
MICROLIFE IT2CA1
K990168 · FLL
Microlife Systems AG
General Hospital · 37d
Cleared Feb 25, 1999
ENDO ANALYZER, MODEL 8005, MODIFIED
K990225 · EAT
Sybron Dental Specialties, Inc.
Dental · 31d
Cleared Feb 25, 1999
SOLO PLUS ORTHO
K990252 · DYH
Sybron Dental Specialties, Inc.
Dental · 29d
Cleared Feb 24, 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...
K980386 · KDI
Gambro Healthcare
Gastroenterology & Urology · 387d
Cleared Feb 24, 1999
SABRATEK 4040 INFUSION PUMP
K980751 · FRN
Sabratek Corp.
General Hospital · 363d
Cleared Feb 24, 1999
FLEXPOSURE RETRACTOR
K983144 · HRX
Endius, Inc.
Orthopedic · 169d
Cleared Feb 24, 1999
PREPARE HOME INFUSION PUMP
K983634 · MEB
Medical Infusion Technologies, Inc.
General Hospital · 132d
Cleared Feb 24, 1999
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K983648 · CBF
Perry Baromedical Services
Anesthesiology · 131d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834 · LPH
Smith & Nephew, Inc.
Orthopedic · 117d