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
77473–77496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099 · MOS
Mri Devices Corp.
Radiology · 8d
Cleared Sep 24, 2001
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
K010892 · LSK
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
K010893 · LSL
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
PROMAX-XP, TENS AND MICROCURRENT DEVICE
K011017 · GZJ
Rehabilicare, Inc.
Neurology · 173d
Cleared Sep 24, 2001
PORTABLE INTENSIVE CARE UNIT
K012030 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 88d
Cleared Sep 24, 2001
VACUETTE EDTA K2 GEL TUBES
K012043 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 87d
Cleared Sep 24, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
K012149 · LYY
Allegiance Healthcare Corp.
General Hospital · 76d
Cleared Sep 24, 2001
AOS MODULAR FEMORAL NAIL
K012190 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 73d
Cleared Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 69d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970 · LNH
GE Medical Systems
Radiology · 20d
Cleared Sep 24, 2001
BREATHABLE IMPERVIOUS GOWNS
K012984 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Sep 21, 2001
INTRA OPERATIVE RADIATION THERAPY
K004023 · IYE
Arplay Medical S.A.
Radiology · 268d
Cleared Sep 21, 2001
PRE-POWDERED NITRILE EXAMINATION GLOVES
K010232 · LZA
P.T. Healthcare Glovindo
General Hospital · 240d
Cleared Sep 21, 2001
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
K010844 · NAK
Astoria-Pacific, Inc.
Chemistry · 184d
Cleared Sep 21, 2001
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
K011340 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
K011341 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
LH 500 ENTERAL FEEDING GRAVITY BAG SET
K011343 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
STS RANGE , MODELS STS20,STS30,STS40
K012008 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 86d
Cleared Sep 21, 2001
AETMED IMAGE PROCESSING SOFTWARE
K012093 · LLZ
Aetmed, S.P.A.
Radiology · 78d
Cleared Sep 21, 2001
AUDIOSCAN VERIFIT, MODEL VF-1
K012306 · ETW
Etymonic Design, Inc.
Ear, Nose, Throat · 60d
Cleared Sep 21, 2001
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
K012329 · CIX
Wiener Laboratories Saic
Chemistry · 60d
Cleared Sep 21, 2001
SQA, SPERM QUALITY ANALYZER
K012352 · POV
Medical Electronic Systems, LLC
Hematology · 58d
Cleared Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456 · ERL
Sodemsystems
Ear, Nose, Throat · 51d