Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78601–78624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 21, 2001
MALE LATEX CONDOM
K012653 · HIS
Qingdao Shuang Die Latex Production...
Obstetrics & Gynecology · 39d
Cleared Sep 21, 2001
COLLAGEN NERVE CUFF
K012814 · JXI
Collagen Matrix, Inc.
Neurology · 30d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED...
K012857 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING...
K012860 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN...
K012863 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
K012904 · GKZ
Bayer Diagnostics Corp.
Hematology · 23d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X...
K000122 · MQV
Neucoll, Inc.
Orthopedic · 611d