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
137593–137616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1987
CHROME-COBALT BASE DENTAL ALLOY
K873661 · EJH
North American Alloys, Inc.
Dental · 67d
Cleared Nov 16, 1987
CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)
K873683 · EBF
Pentron Corp.
Dental · 63d
Cleared Nov 16, 1987
OMNI DIAGNOST
K874113 · IXR
Xre Corp.
Radiology · 38d
Cleared Nov 16, 1987
TRAUMA TABLE II
K874114 · IXR
Xre Corp.
Radiology · 38d
Cleared Nov 16, 1987
MODEL A-17, BEHIND-THE-EAR HEARING AID
K874324 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 13, 1987
MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS
K872039 · EAT
Life-Tech Intl., Inc.
Dental · 170d
Cleared Nov 13, 1987
CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
K872145 · GKL
Cryo Corp.
Pathology · 162d
Cleared Nov 13, 1987
INFUSE-A-PORT ADDITIONAL SIZES
K872329 · LJT
Shiley Infusaid, Inc.
General Hospital · 149d
Cleared Nov 13, 1987
IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)
K873287 · KOD
Todd Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 13, 1987
KEELER CTU CRYO SYSTEM
K873388 · HPS
Keeler Instruments, Inc.
Ophthalmic · 81d
Cleared Nov 13, 1987
UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90
K873575 · LJT
Healthcare Technologies, Inc.
General Hospital · 80d
Cleared Nov 13, 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 13, 1987
ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN
K874213 · DIO
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 28d
Cleared Nov 13, 1987
EMIT TOBRAMYCIN ASSAY
K874223 · KLB
Syva Co.
Toxicology · 28d
Cleared Nov 13, 1987
ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000
K874243 · GAD
Pilling Co.
General & Plastic Surgery · 28d
Cleared Nov 13, 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR BARBITURATE TEST KIT
K874266 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR PCP TEST KIT
K874267 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR MORPHINE TEST KIT
K874268 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR LSD TEST KIT
K874270 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR COCAINE/COCAINE META. TEST
K874271 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · KXS
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874273 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874274 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 24d