FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
122137–122160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1991
CMI TENDER TOUCH VE #303TT AND 404TT
K910788 · HIS
Challenge Mfg., Inc.
Obstetrics & Gynecology · 73d
Cleared May 09, 1991
POWER SCAN 1000
K910802 · LNH
Webb Research, Inc.
Radiology · 72d
Cleared May 09, 1991
LIFELINER SURGICAL GLOVE
K910941 · FYE
Depuy-Raynham
General & Plastic Surgery · 64d
Cleared May 09, 1991
NHS 2009SP HEARING AID
K911174 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 09, 1991
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
K911182 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 09, 1991
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
K911275 · KPS
Positron
Radiology · 48d
Cleared May 09, 1991
CT SYTEC 4000
K911387 · JAK
GE Medical Systems
Radiology · 41d
Cleared May 09, 1991
PERRY(R) ENCORE CHEMOTHERAPY GLOVE
K911633 · LYY
Smith & Nephew Perry
General Hospital · 28d
Cleared May 09, 1991
RAICHEM SPIA C4 REAGENT
K911899 · DBI
Reagents Applications, Inc.
Immunology · 13d
Cleared May 09, 1991
RAICHEM SPIA C3 REAGENT
K911900 · CZW
Reagents Applications, Inc.
Immunology · 13d
Cleared May 08, 1991
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A
K905571 · LIH
Biomedical Life Systems, Inc.
Neurology · 147d
Cleared May 08, 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
K905658 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
K910553 · DER
Roche Diagnostic Systems, Inc.
Immunology · 90d
Cleared May 08, 1991
TRO-GARD
K910678 · KGX
Conmedcorp
General & Plastic Surgery · 82d
Cleared May 08, 1991
ROBICSEK PROBE/RETRACTOR
K910682 · DWP
Bio-Vascular, Inc.
Cardiovascular · 78d
Cleared May 08, 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · LDD
Hewlett-Packard Co.
Cardiovascular · 86d
Cleared May 08, 1991
PROPAQ 102EL, 104EL AND 106EL
K910882 · DRT
Protocol Systems, Inc.
Cardiovascular · 68d
Cleared May 08, 1991
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K910896 · CAI
Specialty Packaging Producs, Inc.
Anesthesiology · 65d
Cleared May 08, 1991
INFLATE-A-CUFF #7014
K910903 · DXQ
Pa Medical Corp.
Cardiovascular · 64d
Cleared May 08, 1991
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
K911060 · KLS
Immunomatrix
Chemistry · 58d
Cleared May 08, 1991
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
K911141 · CGA
Hemocue, Inc.
Chemistry · 55d
Cleared May 08, 1991
QUALTEX SKIN STAPLE EXTRACTOR
K911204 · GDT
Deroyal Industries, Inc.
General & Plastic Surgery · 50d
Cleared May 08, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)
K911389 · JWY
Alamar
Microbiology · 40d
Cleared May 08, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)
K911390 · JWY
Alamar
Microbiology · 40d