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
137977–138000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE
K873751 · DIO
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY
K873752 · DIO
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · LDJ
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE BARBITURATES IN URINE
K873754 · DIS
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY
K873755 · DKZ
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
K873756 · LCM
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE
K873757 · DJG
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE
K873758 · DJG
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT METHAQUALONE
K873759 · KXS
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
MODIFICATION RUBELLA IGM EIA TEST KIT
K873780 · LFX
Labsystems, Inc.
Microbiology · 35d
Cleared Oct 15, 1987
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044 · HWE
Medline Industries, Inc.
Orthopedic · 10d
Cleared Oct 14, 1987
STOMACH EVACULATOR - EWALD STYLE
K864963 · KOA
Medovations, Inc.
Gastroenterology & Urology · 296d
Cleared Oct 14, 1987
PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
K872134 · JWH
Orthomet, Inc.
Orthopedic · 133d
Cleared Oct 14, 1987
P. URINE METER, 250CC
K872824 · KNX
Ni-Med, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 14, 1987
LASER OPTICAL FIBERS - DISPOSABLE
K872870 · LNK
Optimed Therapeutics
Gastroenterology & Urology · 86d
Cleared Oct 14, 1987
PARAGON 9000 TILT AND TURN BED
K872923 · FNL
Surgi-Med, Inc.
General Hospital · 79d
Cleared Oct 14, 1987
USI DENTAL POLISHER. A/G-20
K873147 · EFA
Cranston Ind., Inc.
Dental · 64d
Cleared Oct 14, 1987
HUFFMAN BIOPSY UNIT
K873176 · FCL
Penn Medical Devices, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 14, 1987
DEVINE (SUPRAPUBIC SOUND AND GUIDE)
K873177 · KOE
Penn Medical Devices, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 14, 1987
U-IMPULSE TVC AIR CONDUCTION HEARING AID
K873559 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 42d
Cleared Oct 14, 1987
MODIFIED RECTAL NOZZLE
K873948 · KPL
Colon Therapeutics
Gastroenterology & Urology · 16d
Cleared Oct 13, 1987
ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER
K871526 · EXB
Cox Family Laboratories, Inc.
Gastroenterology & Urology · 176d
Cleared Oct 13, 1987
ISTAT SOFTWARE
K871931 · GWS
Neuroscience, Inc.
Neurology · 147d
Cleared Oct 13, 1987
CHURCHILL ALBUMIN IV ADMINISTRATION SET
K872124 · FPA
Churchill Corp.
General Hospital · 134d