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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83449–83472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2000
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
K993850 · JMT
International Newtech Development, Inc.
Chemistry · 52d
Cleared Jan 03, 2000
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
K993873 · KTT
Alphatec Mfg., Inc.
Orthopedic · 49d
Cleared Jan 03, 2000
DYNATRON 900
K993919 · ITH
Dynatronics Corp.
Physical Medicine · 46d
Cleared Jan 03, 2000
CELSITE, MODELS ST401L, ST405L
K994111 · LJT
B. Braun/Mcgaw
General Hospital · 28d
Cleared Jan 03, 2000
KETAC-MOLAR QUICK
K994251 · EBF
Espe Dental AG
Dental · 17d
Cleared Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 94d
Cleared Dec 30, 1999
THERMOCHEM-HT SYSTEM
K993330 · MLW
Hemocleanse, Inc.
Radiology · 87d
Cleared Dec 30, 1999
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
K993969 · FRO
Winchester Laboratories, LLC
General & Plastic Surgery · 37d
Cleared Dec 30, 1999
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · LZG
Disetronic Medical Systems
General Hospital · 20d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9073
K994219 · DIO
Phamatech
Toxicology · 15d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9078
K994220 · LDJ
Phamatech
Toxicology · 15d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9068
K994233 · LAF
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9083
K994234 · DJG
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9133
K994236 · LCM
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9063
K994237 · DKZ
Phamatech
Toxicology · 14d
Cleared Dec 29, 1999
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT,...
K992148 · CGS
Morax
Chemistry · 188d
Cleared Dec 29, 1999
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992927 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 120d
Cleared Dec 29, 1999
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · KWQ
Depuyacromed
Orthopedic · 113d
Cleared Dec 29, 1999
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
K993283 · LLZ
Arnold & Richter Cine Technik
Radiology · 90d
Cleared Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288 · DXZ
Sulzer Carbomedics, Inc.
Cardiovascular · 89d
Cleared Dec 29, 1999
INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
K993338 · LLZ
Ibm Israel , Ltd.
Radiology · 85d
Cleared Dec 29, 1999
LATEX SURGICAL GLOVES, PRE-POWDERED
K993450 · KGO
Fitco Dipped Products Pvt., Ltd.
General Hospital · 78d
Cleared Dec 29, 1999
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT...
K993529 · LYY
Biografik (Malaysia) Sdn Bhd
General Hospital · 72d
Cleared Dec 29, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
K993542 · DXN
Rossmax International , Ltd.
Cardiovascular · 71d