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
122161–122184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared May 07, 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · DTC
Medtronic Vascular
Cardiovascular · 84d
Cleared May 07, 1991
CARDIOCAP DR-124 RECORDER
K910620 · DRG
Datex Division Instrumentarium Corp.
Cardiovascular · 84d
Cleared May 07, 1991
DISPOSABLE PATIENT CABLE
K910645 · DSA
Diag Corp.
Cardiovascular · 83d
Cleared May 07, 1991
GENESIS I AUTOMATED CELL COUNTER
K910679 · GKL
Alicia Diagnostics, Inc.
Hematology · 81d
Cleared May 07, 1991
DISPOSABLE RETRACTABLE NEEDLE SYRINGE
K910731 · FMF
Safe Tech Medical Products, Inc.
General Hospital · 76d
Cleared May 07, 1991
MET-ETCH
K910813 · EBC
Gresco Products, Inc.
Dental · 70d
Cleared May 07, 1991
QBC AUTOREADER
K910834 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 69d
Cleared May 07, 1991
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K910861 · DYB
Daig Corp.
Cardiovascular · 81d
Cleared May 07, 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · DRF
C.R. Bard, Inc.
Cardiovascular · 54d