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
76921–76944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2002
QACA IGG/IGM ELISA KIT
K020241 · MID
Cheshire Diagnostics , Ltd.
Immunology · 49d
Cleared Mar 13, 2002
LIFESTYLE OXYGEN CONCENTRATOR
K020324 · CAW
Airsep Corp.
Anesthesiology · 41d
Cleared Mar 13, 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · HWC
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
K020573 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Mar 13, 2002
MTP CLEARVISION DISPOSABLE TUBING SET
K020599 · EOB
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 19d
Cleared Mar 13, 2002
NVA-63-8 NEUROVASCULAR ARRAY COIL
K020606 · MOS
Mri Devices Corp.
Radiology · 16d
Cleared Mar 12, 2002
HIGHGATE CURVED ROD SYSTEM
K012045 · KWQ
Highgate Orthopaedics
Orthopedic · 256d
Cleared Mar 12, 2002
PREFERNCE IMRT TREATMENT PLANNING MODULE
K012575 · MUJ
Northwest Medical Physics Equipment,...
Radiology · 215d
Cleared Mar 12, 2002
SONOPSY
K013109 · FCG
Hakko Medical Co., Ltd.
Gastroenterology & Urology · 176d
Cleared Mar 12, 2002
IN-TIME RETRIEVAL DEVICE
K014109 · MMX
Boston Scientific, Target
Cardiovascular · 88d
Cleared Mar 12, 2002
GREAT TOE IMPLANT SYSTEM
K014164 · KWD
Harmos Orthopaedics, Inc.
Orthopedic · 83d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 12, 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · MRW
Nuvasive, Inc.
Orthopedic · 33d
Cleared Mar 12, 2002
RBM
K020480 · KGS
Smith & Nephew, Inc.
General & Plastic Surgery · 27d
Cleared Mar 12, 2002
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · KPE
Baxter Healthcare Corp
General Hospital · 27d
Cleared Mar 12, 2002
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES
K020544 · FPA
Churchill Medical Systems, Inc.
General Hospital · 25d
Cleared Mar 12, 2002
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
K020725 · FLL
Microlife Corp.
General Hospital · 6d
Cleared Mar 11, 2002
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377 · HSD
Corin USA
Orthopedic · 228d
Cleared Mar 11, 2002
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX,...
K012869 · HIH
Gimmi GmbH
Obstetrics & Gynecology · 196d
Cleared Mar 11, 2002
VISTITOME 20-10 MICROKERATOME
K014000 · HNO
Biovision AG
Ophthalmic · 97d
Cleared Mar 11, 2002
ENDIUS SPINAL FIXATION SYSTEM
K014090 · KWP
Endius, Inc.
Orthopedic · 90d
Cleared Mar 08, 2002
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960 · MXZ
Biogenex Laboratories
Pathology · 185d
Cleared Mar 08, 2002
ACT 11 MP VENTRICULAR CATHETER
K013005 · HCA
Innerspace, Inc.
Neurology · 183d