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
126889–126912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1990
NIL STERILE LATEX EXAMINATION GLOVES
K900648 · LYY
United Lion Rubber Industries Sdn. Bhd.
General Hospital · 27d
Cleared Mar 08, 1990
LATEX EXAMINATION GLOVES
K900650 · LYY
Shenzhen Guang JI Emulsion Products...
General Hospital · 27d
Cleared Mar 08, 1990
MODIFIED CAPTIA(R) SYPHILIS-M
K900654 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 27d
Cleared Mar 08, 1990
BIODYNE INSTRUMENT WIPES
K900691 · GEC
Bio-Dyne, Inc.
General & Plastic Surgery · 23d
Cleared Mar 07, 1990
VERIMED MYOEXORCISER VERISTIM
K893220 · IPF
Verimed Holdings, Inc.
Physical Medicine · 314d
Cleared Mar 07, 1990
LE PTA CATHETER
K894250 · LIT
Baxter Healthcare Corp
Cardiovascular · 259d
Cleared Mar 07, 1990
ANGIOSCOPE
K894459 · LYK
Intramed Laboratories, Inc.
Cardiovascular · 232d
Cleared Mar 07, 1990
ORAD TOOTHBRUSH CLEANER
K895345 · EFT
Orad, Inc.
Dental · 188d
Cleared Mar 07, 1990
POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL
K895988 · EMA
Milton Hodosh, M.D.
Dental · 146d
Cleared Mar 07, 1990
ERECTION DEVICE
K896061 · LKY
Clyde Engineering Service
Gastroenterology & Urology · 140d
Cleared Mar 07, 1990
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 127d
Cleared Mar 07, 1990
BALLOON DILATION CATHETER
K896448 · EZN
Cook Ob/Gyn
Gastroenterology & Urology · 118d
Cleared Mar 07, 1990
DYNATORQ DENTAL HANDPIECE ATTACHMENTS
K896876 · EFB
Micro Motors, Inc.
Dental · 89d
Cleared Mar 07, 1990
DENTAL AIR MOTORS (SEVERAL MODELS)
K896877 · EFB
Micro Motors, Inc.
Dental · 89d
Cleared Mar 07, 1990
ORAL SURGERY HANDPIECE AND ATTACHMENTS
K896879 · EFB
Micro Motors, Inc.
Dental · 89d
Cleared Mar 07, 1990
THERMOSCAN-INSTANT THERMOMETER MODEL IR-2000
K896952 · FLL
Thermoscan, Inc.
General Hospital · 82d
Cleared Mar 07, 1990
WILSON-COOK COLON DECOMPRESSION SET
K900035 · FEG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 07, 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413 · IPF
Chattanooga Group, Inc.
Physical Medicine · 43d
Cleared Mar 06, 1990
COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
K884235 · DRS
Burron Medical, Inc.
Cardiovascular · 515d
Cleared Mar 06, 1990
IMPLANTABLE ADAPTOR 033-380
K890895 · DTD
Telectronics, Inc.
Cardiovascular · 377d
Cleared Mar 06, 1990
MODEL JM-1 CO2 LASER
K892912 · GEX
L.A.S.E.R., Inc.
General & Plastic Surgery · 320d
Cleared Mar 06, 1990
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F
K894563 · DXN
Omron Electronics, Inc.
Cardiovascular · 228d
Cleared Mar 06, 1990
UNIVOX-IC
K895356 · DTN
Baxter Healthcare Corp
Cardiovascular · 190d
Cleared Mar 06, 1990
BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
K895645 · IYO
Biosound, Inc.
Radiology · 167d