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
127489–127512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 06, 1990
TELEREHAB SYSTEM FOR CARDIAC REHABILITATION
K895719 · DXH
Scottcare Corp.
Cardiovascular · 162d
Cleared Mar 06, 1990
CAPTIA(R) CMV-G
K896194 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 132d
Cleared Mar 06, 1990
CAPTIA(R) CMV-M
K896295 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 126d
Cleared Mar 06, 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · DTB
Medtronic Vascular
Cardiovascular · 125d
Cleared Mar 06, 1990
MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
K896403 · LIT
Intensive Technology, Inc.
Cardiovascular · 119d
Cleared Mar 06, 1990
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
K896482 · LCX
Pacific Biotech, Inc.
Chemistry · 113d
Cleared Mar 06, 1990
EXPLORER 24 DENTAL HAND INSTRUMENT
K896843 · EKJ
American Medical Ceramics, Inc.
Dental · 90d
Cleared Mar 06, 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920 · DSP
Boston Scientific Corp
Cardiovascular · 84d
Cleared Mar 06, 1990
HYCOR ACCUPINCH COCAINE TEST
K896937 · DIO
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Mar 06, 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d