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

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175,820 results
50737–50760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2010
LIFEGLOBAL PROTEIN SUPPLEMENT
K092578 · MQL
Intl., Inc.
Obstetrics & Gynecology · 227d
Cleared Apr 05, 2010
CENTURY MODEL 105C
K093341 · EFB
Sybron Dental Specialties, Inc.
Dental · 164d
Cleared Apr 05, 2010
MODEL DGH 6000 SCANMATE A
K093371 · IYO
Dgh Technology, Inc.
Radiology · 158d
Cleared Apr 05, 2010
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
K093632 · CBK
Drager Medical AG & Co. Kgaa
Anesthesiology · 133d
Cleared Apr 05, 2010
SIMONDR DRP
K093790 · MQB
Simondr, Inc.
Radiology · 116d
Cleared Apr 05, 2010
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K093935 · MBI
Smith & Nephew, Inc.
Orthopedic · 104d
Cleared Apr 05, 2010
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
K100023 · DJG
Medtox Diagnostics, Inc.
Toxicology · 90d
Cleared Apr 05, 2010
MR INSPIRE WITH EXTENDED KIT
K100164 · LNH
Paramed S.R.L.
Radiology · 75d
Cleared Apr 05, 2010
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR,...
K100599 · OLO
Orthosoft, Inc.
Orthopedic · 33d
Cleared Apr 05, 2010
S-SCAN, MODEL 9800020010
K100670 · MOS
Esaote, S.P.A.
Radiology · 27d
Cleared CT Apr 02, 2010
VITALA CONTINENCE CONTROL DEVICE
K083785 · EZQ
Convatec
Gastroenterology & Urology · 469d
Cleared Apr 02, 2010
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
K091716 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 296d
Cleared Apr 02, 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · BWK
Inno-Health Technology, Inc.
Neurology · 276d
Cleared Apr 02, 2010
STRYKER SONICPIN SYSTEM
K091955 · HTY
Howmedica Osteonics Corp.
Orthopedic · 275d
Cleared Apr 02, 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · MNI
Corentec Co., Ltd.
Orthopedic · 267d
Cleared Apr 02, 2010
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED...
K092481 · FIP
New Aqua, LLC (Dba Aqua Systems)
Gastroenterology & Urology · 232d
Cleared Apr 02, 2010
HELIOX LOW FLOW SENTRY BLENDER
K092484 · BZR
Cardinal Health 207, Inc.
Anesthesiology · 232d
Cleared Apr 02, 2010
SPRYTIE, MODELS ST001, ST002 AND ST003
K092530 · DZK
Russell B. Walther
Dental · 227d
Cleared Apr 02, 2010
INTRAUTERINE INSEMINATION (IUI) CATHETER
K092579 · MQF
Fertiligent, Ltd.
Obstetrics & Gynecology · 228d
Cleared Apr 02, 2010
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS...
K092785 · DSH
Vasomedical, Inc.
Cardiovascular · 204d
Cleared Apr 02, 2010
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
K093135 · BTR
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 179d
Cleared Apr 02, 2010
ENHANCED ULTRA VIT PROBE
K093305 · MLZ
Alcon Research, Ltd.
Ophthalmic · 162d
Cleared Apr 02, 2010
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
K093321 · DZE
BioHorizons Implant Systems, Inc.
Dental · 161d
Cleared Apr 02, 2010
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER),...
K093333 · FLE
Primus Sterilizer Company, LLC
General Hospital · 158d