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
111841–111864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1993
CARDIOMETRICS FLOWIRE & FLOMAP
K932536 · ITX
Cardio Metrics, Inc.
Radiology · 125d
Cleared Sep 28, 1993
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758 · JHI
Medix Biotech, Inc.
Chemistry · 117d
Cleared Sep 28, 1993
MAYFIELD* A-2000 SKULL CLAMP
K932807 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 111d
Cleared Sep 28, 1993
EVACUATOR, ORAL CAVITY
K932824 · EIA
Den-Tal-Ez Mfg Co., Inc.
Dental · 111d
Cleared Sep 28, 1993
MAYFIELD ADULT DISPOSABLE SKULL PIN
K932860 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 109d
Cleared Sep 28, 1993
KODAK XML 300 DARKROOM FILM FEEDER
K933001 · IXW
Eastman Kodak Company
Radiology · 99d
Cleared Sep 28, 1993
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · DQY
C.R. Bard, Inc.
Cardiovascular · 98d
Cleared Sep 28, 1993
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW
K933058 · IZI
Heartware Intl. Corp.
Radiology · 98d
Cleared Sep 27, 1993
UREA KIT
K923506 · CDQ
Randox Laboratories, Ltd.
Chemistry · 439d
Cleared Sep 27, 1993
VITAPEN
K924447 · KZF
Vitajet Corp.
General Hospital · 391d
Cleared Sep 27, 1993
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K925248 · DSP
Kontron Instruments, Inc.
Cardiovascular · 346d
Cleared Sep 27, 1993
SELEC-3
K925645 · FPA
Biomedix, Inc.
General Hospital · 322d
Cleared Sep 27, 1993
EZ PUMP
K926446 · FRW
Alphamed, Inc.
General Hospital · 278d
Cleared Sep 27, 1993
SYNELISA CORTISOL
K931177 · CGR
Elias U.S.A., Inc.
Chemistry · 202d
Cleared Sep 27, 1993
VITAL-PORT MINI VASCULAR ACCESS SYSTEM
K931586 · DWF
Med Institute, Inc.
Cardiovascular · 180d
Cleared Sep 27, 1993
CALCIUM TEST ITEM NUMBER 65409
K932158 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 27, 1993
URIC ACID TEST ITEM NUMBER 65422
K932162 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 27, 1993
LAP CHOLY TRAYS (PACKS)
K932220 · LRO
Associated Medical Products Co.
General & Plastic Surgery · 143d
Cleared Sep 27, 1993
BIOCLOT LA
K932463 · GIR
Biopool AB
Hematology · 129d
Cleared Sep 24, 1993
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K921956 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 515d
Cleared Sep 24, 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 515d
Cleared Sep 24, 1993
INSUFFLATOR TUBING KIT
K922197 · HIG
O.R. Concepts, Inc.
Obstetrics & Gynecology · 501d
Cleared Sep 24, 1993
INSUFFLATOR TUBING/FILTER KIT
K922244 · HIF
O.R. Concepts, Inc.
Obstetrics & Gynecology · 499d
Cleared Sep 24, 1993
MICROSNARE
K925439 · DQY
Microvena Corp.
Cardiovascular · 331d