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
54409–54432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2009
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
K082833 · KTT
Nutek Orthopaedics, Inc.
Orthopedic · 132d
Cleared Feb 05, 2009
BIODRIVE CANNULATED SCREW SYSTEM
K082874 · HWC
Biomet Trauma
Orthopedic · 129d
Cleared Feb 05, 2009
PORTABLE X-RAY SYSTEM, MODEL DXR -1
K082875 · EHD
Exaro Co., Ltd.
Radiology · 129d
Cleared Feb 05, 2009
TENS-EMS-14
K083030 · GZJ
Emsi
Neurology · 118d
Cleared Feb 05, 2009
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
K083439 · MBF
Synthes (Usa)
Orthopedic · 77d
Cleared Feb 05, 2009
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
K083684 · KNT
Manufacturing & Research, Inc.
Gastroenterology & Urology · 55d
Cleared Feb 05, 2009
SICAT IMPLANT
K090119 · LLZ
Sicat GmbH & Co. KG
Radiology · 15d
Cleared Feb 05, 2009
NUOVOGUARD
K090122 · FOZ
U.S. Safety Syringes Co., Inc.
General Hospital · 15d
Cleared Feb 05, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K090173 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 13d
Cleared Feb 04, 2009
IRRISEPT WOUND CLEANSING SYSTEM
K080779 · FQH
Irrimax Corporation
General & Plastic Surgery · 322d
Cleared Feb 04, 2009
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
K080910 · NOT
Bioimagene, Inc.
Pathology · 309d
Cleared Feb 04, 2009
GELX ORAL GEL
K081372 · OLR
Bmg Pharma, LLC
General & Plastic Surgery · 264d
Cleared Feb 04, 2009
CELL-DYN EMERALD SYSTEM
K081495 · GKZ
Abbott Laboratories
Hematology · 251d
Cleared Feb 04, 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K081947 · DTN
Gish Biomedical, Inc.
Cardiovascular · 211d
Cleared Feb 04, 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K082082 · DTN
Gish Biomedical, Inc.
Cardiovascular · 196d
Cleared Feb 04, 2009
MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
K082150 · NTW
Preanalytix GmbH
Pathology · 189d
Cleared Feb 04, 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082691 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 142d
Cleared Feb 04, 2009
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
K083034 · GEX
Fotona D.D.
General & Plastic Surgery · 117d
Cleared Feb 04, 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
K083153 · KNT
Hollister, Inc.
Gastroenterology & Urology · 103d
Cleared CT Feb 04, 2009
GORE FLOW REVERSAL SYSTEM
K083300 · NTE
W.L. Gore & Associates, Inc.
Cardiovascular · 86d
Cleared Feb 04, 2009
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 70d
Cleared Feb 04, 2009
EEA HEMORRHOID STAPLER & ACCESSORIES
K083781 · GDW
Surgical Devices, A Global Business...
General & Plastic Surgery · 47d
Cleared Feb 04, 2009
SURGIMEND
K083898 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 37d
Cleared Feb 04, 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K090170 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 12d