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
111289–111312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1993
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
K931968 · DRY
3M Health Care, Ltd.
Cardiovascular · 203d
Cleared Nov 10, 1993
FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
K932301 · FPB
Baxter Healthcare Corp
General Hospital · 182d
Cleared Nov 10, 1993
EVA EMPTY MIXING CONTAINER
K932640 · KPE
Douglas Medical Products Corp.
General Hospital · 161d
Cleared Nov 10, 1993
EMPTY MIXING CONTAINER
K932641 · KPE
Douglas Medical Products Corp.
General Hospital · 161d
Cleared Nov 10, 1993
ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR
K932697 · GCJ
Innovative Surgical, Inc.
General & Plastic Surgery · 160d
Cleared Nov 10, 1993
ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
K933868 · GCT
Angiolaz, Inc.
Gastroenterology & Urology · 96d
Cleared Nov 09, 1993
ITC CONTOUR EMBOLI, MODIFICATION
K914866 · HCG
Interventional Therapeutics Corp.
Neurology · 742d
Cleared Nov 09, 1993
ELECTRIC POWERED BREAST PUMP
K921261 · HGX
Schuco, Inc.
Obstetrics & Gynecology · 603d
Cleared Nov 09, 1993
OSTEOMED GREAT TOE SYSTEM
K922211 · LZJ
Osteomed Corp.
Orthopedic · 546d
Cleared Nov 09, 1993
THE WESTERN CORTICAL ELECTRODE ARRAY
K923330 · GYC
University Hospital (London)...
Neurology · 490d
Cleared Nov 09, 1993
COBE CMS-FS MEMBRANE OXYGENATOR
K926467 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 316d
Cleared Nov 09, 1993
MITEK CONE WASHER
K930675 · KGS
Mitek Surgical Products, Inc.
General & Plastic Surgery · 273d
Cleared Nov 09, 1993
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
K931923 · GWF
Dantec Medical, Inc.
Neurology · 207d
Cleared Nov 09, 1993
AIA-PACK E2 ASSAY
K932084 · CHP
Tosoh Medics, Inc.
Chemistry · 193d
Cleared Nov 09, 1993
PERCUTANEOUS INTRODUCER
K932323 · DYB
Medamicus, Inc.
Cardiovascular · 182d
Cleared Nov 09, 1993
REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET
K932370 · DYB
Remington Medical, Inc.
Cardiovascular · 179d
Cleared Nov 09, 1993
IRON/UIBC REAGENT
K932517 · JMO
Sigma Diagnostics, Inc.
Chemistry · 168d
Cleared Nov 09, 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · CGA
Cholestech Corp.
Chemistry · 158d
Cleared Nov 09, 1993
LIFE-AIR 1000 PATIENT WARMING COVER
K933764 · DWJ
Progressive Dynamics, Inc.
Cardiovascular · 110d
Cleared Nov 09, 1993
DUPONT ACA URINE METHADONE CALIBRATOR
K934144 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Nov 09, 1993
DUPONT ACA URINE METHADONE CONTROL
K934145 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Nov 09, 1993
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · DJR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Nov 09, 1993
BECKMAN SYNCHRON LACTATE REAGENT
K934271 · KHP
Beckman-Diagnostic Systems Group
Chemistry · 70d
Cleared Nov 08, 1993
DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
K921716 · HET
American Surgical Instruments Corp.
Obstetrics & Gynecology · 578d