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

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175,820 results
124321–124344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1990
CLINICAL BLOOD GAS MIXTURES
K904163 · LCH
Norco, Inc.
Chemistry · 51d
Cleared Nov 01, 1990
THROMBELASTOGRAPH
K904204 · GKP
Haemoscope Corp.
Hematology · 50d
Cleared Nov 01, 1990
PERTAC UNIVERSAL BOND
K904289 · KLE
Espe GmbH (Us)
Dental · 45d
Cleared Nov 01, 1990
ARGENCO 19
K904437 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Nov 01, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
K904497 · DCN
Biotrax, Inc.
Immunology · 30d
Cleared Nov 01, 1990
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
K904635 · LDJ
Immunotech Corp.
Toxicology · 21d
Cleared Nov 01, 1990
OTICAON BTE MODEL E34P
K904673 · ESD
Oticon Corp.
Ear, Nose, Throat · 20d
Cleared Oct 31, 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · LIT
Boston Scientific Corp
Cardiovascular · 296d
Cleared Oct 31, 1990
BARD MICROBORE ANTI-SIPHON NITRO SET
K900217 · FRN
C.R. Bard, Inc.
General Hospital · 287d
Cleared Oct 31, 1990
CUSTOMED CYSTO PACK II
K901705 · KKX
Customed, Inc.
General Hospital · 202d
Cleared Oct 31, 1990
INVOTEC POLY-MESH MANDIBULAR TRAY
K901923 · JAZ
Invotec International, Inc.
Ear, Nose, Throat · 184d
Cleared Oct 31, 1990
CUSTOMED LAP PACK II
K902191 · KKX
Customed, Inc.
General Hospital · 168d
Cleared Oct 31, 1990
OMRON PULSE STIMULATOR MODEL HV-F05
K902255 · IPF
Omron Electronics, Inc.
Physical Medicine · 163d
Cleared Oct 31, 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478 · LDD
Physio-Control Corp.
Cardiovascular · 149d
Cleared Oct 31, 1990
SCOPESCRUBBER(TM)
K902683 · EOB
Healthtek Microsurgical, Inc.
Ear, Nose, Throat · 134d
Cleared Oct 31, 1990
PRIZM HEARING SYSTEM
K902846 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 125d
Cleared Oct 31, 1990
HME-10 (TM)
K903054 · BYD
Pharma Systems, Inc.
Anesthesiology · 112d
Cleared Oct 31, 1990
GERARD MEDICAL, INC. TRIM-PORT
K903364 · LJT
Gerard Medical Enterprises, Inc.
General Hospital · 97d
Cleared Oct 31, 1990
BIO-MEDICUS CANNULA INTRODUCER
K903410 · DYB
Bio Medicus, Inc.
Cardiovascular · 92d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
K903747 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
K903748 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
K903749 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
K903750 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
K903816 · EZK
Respiratory Support Products, Inc.
Gastroenterology & Urology · 72d