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
76177–76200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2002
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT...
K013254 · LZA
Top Quality Mfg., Inc.
General Hospital · 129d
Cleared Feb 04, 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · FDS
Pentax Precision Instrument Corp.
Radiology · 91d
Cleared Feb 04, 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 04, 2002
BERCHTOLD ELEKTROTOM 106 HITT
K013668 · GEI
Berchtold Corp.
General & Plastic Surgery · 90d
Cleared Feb 04, 2002
ENDO-GLIDE
K013701 · GCJ
Sonotech, Inc.
General & Plastic Surgery · 88d
Cleared Feb 04, 2002
TEMPFIL
K013895 · EBG
Sybron Dental Specialties, Inc.
Dental · 73d
Cleared Feb 04, 2002
VERAVIEWEPOCS, MODEL VE
K013955 · EHD
J. Morita USA, Inc.
Radiology · 66d
Cleared Feb 04, 2002
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K014077 · LZA
Shijiazhuang Great Vision Plastic...
General Hospital · 55d
Cleared Feb 04, 2002
DEMETRON LC
K014179 · EBZ
Kerr Corp.
Dental · 46d
Cleared Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 19d
Cleared Feb 01, 2002
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
K011901 · MKJ
Survivalink Corp.
Cardiovascular · 228d
Cleared Feb 01, 2002
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
K012241 · DSI
Cardionet, Inc.
Cardiovascular · 199d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 193d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966 · JJF
Roche Molecular Systems, Inc.
Chemistry · 150d
Cleared Feb 01, 2002
XENALIGHT MODELS # AX9125 (100-120V~)
K013511 · FSW
Aculux, Inc.
General & Plastic Surgery · 102d
Cleared Feb 01, 2002
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
K013611 · GCJ
Henke Sass Wolf of America, Inc.
General & Plastic Surgery · 88d
Cleared Feb 01, 2002
TROJAN CRYSTAL CLEAR LIQUID
K013614 · NUC
Armkel, LLC
Obstetrics & Gynecology · 88d
Cleared Feb 01, 2002
SOFTIQUE, MODEL GI 11001
K013707 · IMC
Global TV Concepts, Ltd.
Physical Medicine · 85d
Cleared Feb 01, 2002
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826 · KPR
Siemens Medical Systems, Inc.
Radiology · 74d
Cleared Feb 01, 2002
TM2000, MODEL 1
K013879 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 70d
Cleared Feb 01, 2002
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885 · MNI
Blackstone Medical, Inc.
Orthopedic · 70d
Cleared Feb 01, 2002
SCANX
K013893 · MUH
Air Techniques, Inc.
Radiology · 70d
Cleared Feb 01, 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · JKA
Becton, Dickinson & CO
Hematology · 60d
Cleared Feb 01, 2002
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
K013985 · MOS
Machnet BV
Radiology · 60d