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
123937–123960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1990
VOLUMETRIC INFUSION PUMP
K904518 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 14d
Cleared Oct 16, 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · LIT
Boston Scientific Corp
Cardiovascular · 299d
Cleared Oct 16, 1990
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
K900607 · DSI
Cardiodata Corp.
Cardiovascular · 250d
Cleared Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
K902143 · DWP
Baxter Healthcare Corp
Cardiovascular · 154d
Cleared Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · LDF
Medtronic Vascular
Cardiovascular · 144d
Cleared Oct 16, 1990
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K902518 · DTM
Pall Biomedical Products Co.
Cardiovascular · 132d
Cleared Oct 16, 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · DYB
Datascope Corp.
Cardiovascular · 105d
Cleared Oct 16, 1990
TOXO IGM ELISA TEST
K903324 · LGD
Gull Laboratories, Inc.
Microbiology · 83d
Cleared Oct 16, 1990
CHLAMYDIA ACCU-CULSHURE TM
K903405 · LIO
Medical Laboratory Automation...
Microbiology · 77d
Cleared Oct 16, 1990
VIRAL ACCU-CULSHURE TM
K903406 · LIO
Medical Laboratory Automation...
Microbiology · 77d
Cleared Oct 16, 1990
OPTIMED GLAUCOMA PRESSURE REGULATOR
K903462 · KYF
Optimed, Inc.
Ophthalmic · 76d
Cleared Oct 16, 1990
EBV/EA-CHECK TM TEST KIT
K903612 · LSE
Diagnostic Technology, Inc.
Microbiology · 68d
Cleared Oct 16, 1990
TURBIQUANT MYOGLOBIN
K903687 · DDR
Behring Diagnostics, Inc.
Immunology · 62d
Cleared Oct 16, 1990
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
K903810 · HWC
Ace Medical Co.
Orthopedic · 57d
Cleared Oct 16, 1990
ACE CANNULATED CORTICAL BONE SCREW
K903811 · HWC
Ace Medical Co.
Orthopedic · 57d
Cleared Oct 16, 1990
GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY
K903840 · DYB
Intec Medical, Inc.
Cardiovascular · 56d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
K903927 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
K903928 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · LIN
Baxter Healthcare Corp
Microbiology · 41d
Cleared Oct 16, 1990
DACRON R SURGICAL SUTURES
K904263 · GAS
Sharppoint, Inc.
General & Plastic Surgery · 29d
Cleared Oct 16, 1990
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · LYF
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Oct 15, 1990
DEMISTIFIER ISOLATION CHAMBER
K902161 · CBN
Peace Medical, Inc.
Anesthesiology · 153d
Cleared Oct 15, 1990
GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR
K902906 · FLI
Gas-Vak
General Hospital · 104d