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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121561–121584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 08, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)
K911391 · JWY
Alamar
Microbiology · 40d
Cleared May 08, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN
K911392 · JWY
Alamar
Microbiology · 40d
Cleared May 08, 1991
OMNICATH IMPLANTED CATHETER AND DEPOT
K911775 · KXK
Omnitron Intl., Inc.
Radiology · 37d
Cleared May 08, 1991
QUALTEX SUTURE BOOTIES
K911895 · MDM
Deroyal Industries, Inc.
General & Plastic Surgery · 9d
Cleared May 08, 1991
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · DAD
Reagents Applications, Inc.
Immunology · 12d
Cleared May 07, 1991
PYLORI STAT TEST KIT
K904738 · LYR
Whittaker Bioproducts, Inc.
Microbiology · 201d
Cleared May 07, 1991
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049 · LYR
Quidel Corp.
Microbiology · 180d
Cleared May 07, 1991
TRIOS 02
K905087 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 175d
Cleared May 07, 1991
A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER
K905114 · JOM
Research Consultants, Inc.
Cardiovascular · 175d
Cleared May 07, 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182 · DTB
Oscor Medical Corp.
Cardiovascular · 169d
Cleared May 07, 1991
PERMANENT PACING LEAD
K905300 · DTB
Oscor Medical Corp.
Cardiovascular · 161d
Cleared May 07, 1991
PYLORI-G FIAX TEST KIT
K905468 · LYR
Whittaker Bioproducts, Inc.
Microbiology · 152d
Cleared May 07, 1991
CARD GUARD-3000 ECG TELEPHONE ADAPTER
K910450 · DXH
Medtech Industries, Inc.
Cardiovascular · 95d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d