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
88609–88632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1998
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET...
K981713 · MGP
Smith & Nephew, Inc.
General & Plastic Surgery · 77d
Cleared Jul 31, 1998
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
K981889 · FCG
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared Jul 31, 1998
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Jul 31, 1998
PRODIGY 2
K982148 · EBF
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Jul 31, 1998
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
K982302 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 31, 1998
MANIFOLD WITH EXTENSION SET
K982368 · FMG
Interpore Cross Intl.
General Hospital · 24d
Cleared Jul 31, 1998
IMAGYN 125 I SEED, MODEL IS 125
K982421 · IWG
International Isotopes, Inc.
Radiology · 18d
Cleared Jul 31, 1998
GENESIS IMRT LINEAR ACCELERATOR
K982502 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 31, 1998
MX MEVATRON
K982513 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 30, 1998
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913 · HRS
Pacific Materials and Interfaces
Orthopedic · 357d
Cleared Jul 30, 1998
DIPSTREAK
K974428 · JSI
Novamed , Ltd.
Microbiology · 248d
Cleared Jul 30, 1998
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
K980573 · CGA
Chronimed, Inc.
Chemistry · 163d
Cleared Jul 30, 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · LYR
Zeus Scientific, Inc.
Microbiology · 149d
Cleared Jul 30, 1998
PYLORIPROBE
K981396 · LYR
Amdl, Inc.
Microbiology · 104d
Cleared Jul 30, 1998
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
K981562 · EBF
Sulzer Calcitek, Inc.
Dental · 90d
Cleared Jul 30, 1998
ELECTROSURGICAL BASKET ELECTRODES...
K981589 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 87d
Cleared Jul 30, 1998
SNAP-N-PEEL INTRODUCERS
K981611 · KNY
Circon Corp.
Gastroenterology & Urology · 85d
Cleared Jul 30, 1998
HEPTRAC ELECTRONIC QUALITY CONTROL
K981815 · JPA
Medtronic Blood Management
Hematology · 69d
Cleared Jul 30, 1998
UIBC
K982041 · JMO
Abbott Laboratories
Chemistry · 50d
Cleared Jul 30, 1998
PASCO MIC AND MIC/ID PANELS
K982235 · JTN
Pasco Laboratories, Inc.
Microbiology · 35d
Cleared Jul 30, 1998
DURA-GUARD - DURAL REPAIR PATCH
K982282 · GXQ
Bio-Vascular, Inc.
Neurology · 30d
Cleared Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · LBS
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Jul 29, 1998
OLYMPUS NEURO ENDOSCOPE
K971340 · GWG
Olympus Optical, Co.
Neurology · 475d
Cleared Jul 29, 1998
MICRO II MICROCURRENT TENS
K973978 · GZJ
Apex Medical Corp.
Neurology · 282d