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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
42049–42072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2013
MONOJECT 12ML SYRINGE
K130049 · FMF
Nipro Medical Corporation
General Hospital · 37d
Cleared Feb 14, 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Feb 13, 2013
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
K120236 · DDG
The Binding Site Group , Ltd.
Immunology · 384d
Cleared Feb 13, 2013
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
K121826 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 237d
Cleared Feb 13, 2013
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
K123097 · JAA
Toshiba America Medical Systems, In.C
Radiology · 134d
Cleared Feb 13, 2013
ULTRASOUND SCANNER FLEX FOCUS
K123254 · IYN
B-K Medical Aps
Radiology · 118d
Cleared Feb 13, 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K123412 · OSH
K2m, Inc.
Orthopedic · 99d
Cleared Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · JXG
Medtronic Neurosurgery
Neurology · 90d
Cleared Feb 12, 2013
FORYOU NPWT DEVICE
K113236 · OMP
Foryou Medical Electronics Co, Ltd.
General & Plastic Surgery · 468d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · NBW
Roche Diagnostics
Chemistry · 434d
Cleared Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · MYA
Dako North America, Inc.
Pathology · 344d
Cleared Feb 12, 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM...
K121877 · KWP
Exactech, Inc.
Orthopedic · 229d
Cleared Feb 12, 2013
NEW STETIC ARTIFICIAL TEETH
K122925 · ELM
New Stetic
Dental · 141d
Cleared Feb 12, 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
K123544 · LIT
Ev3, Inc.
Cardiovascular · 85d
Cleared Feb 12, 2013
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
K123705 · LZO
Corin USA
Orthopedic · 71d
Cleared Feb 12, 2013
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR...
K123938 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Feb 12, 2013
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K130043 · CAC
Teleflexmedical, Inc.
Anesthesiology · 35d
Cleared Feb 12, 2013
STA COMPACT MAX
K130090 · JPA
Diagnostica Stago, Incorporated
Hematology · 29d
Cleared Feb 12, 2013
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE...
K130209 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 14d
Cleared Feb 11, 2013
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K102751 · NBW
Ceragem Medisys, Inc.
Chemistry · 872d
Cleared Feb 11, 2013
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
K121069 · MSH
3M Company
General Hospital · 308d
Cleared Feb 11, 2013
J-SCOPE SYSTEM
K122411 · HRX
Myelotec
Orthopedic · 187d
Cleared Feb 11, 2013
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
K123116 · LZA
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 131d
Cleared Feb 11, 2013
IPL THERAPY SYSTEM
K123435 · ONF
Beijing Sincoheren S&T Development...
General & Plastic Surgery · 96d