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
86953–86976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1999
MTM BIOSCANNER K TEST STRIPS
K981865 · JMK
Polymer Technology Systems, Inc.
Chemistry · 274d
Cleared Feb 26, 1999
SURE
K982380 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 233d
Cleared Feb 26, 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663 · MQV
Encore Orthopedics, Inc.
Orthopedic · 211d
Cleared Feb 26, 1999
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
K983204 · HFW
Harwill Medical (Pty) , Ltd.
Obstetrics & Gynecology · 165d
Cleared Feb 26, 1999
7F HYDROLYSER THROMBECTOMY CATHETER
K983534 · QEZ
Cordis Corp.
Cardiovascular · 140d
Cleared Feb 26, 1999
HSV 1+2 IGG ELISA TEST
K983541 · LGC
Gull Laboratories, Inc.
Microbiology · 140d
Cleared Feb 26, 1999
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER...
K984363 · BTA
Xomed, Inc.
General & Plastic Surgery · 81d
Cleared Feb 26, 1999
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
K984503 · KLE
Wallace A. Erickson & Co.
Dental · 70d
Cleared Feb 26, 1999
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST
K984525 · DKZ
American Bio Medica Corp.
Toxicology · 67d
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