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
51409–51432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2010
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · DSY
Vascutek, Ltd.
Cardiovascular · 27d
Cleared Jan 06, 2010
MICHIGAN CRANIAL RESHAPING ORTHOSIS
K090341 · MVA
Danmar Products, Inc.
Neurology · 330d
Cleared Jan 06, 2010
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
K092162 · MAX
Solco Biomedical Co., Ltd.
Orthopedic · 174d
Cleared Jan 06, 2010
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
K092772 · EHD
Hanjin Digi-X Co., Ltd.
Radiology · 119d
Cleared Jan 06, 2010
CYTORI PUREGRAFT 250/PURE SYSTEM
K092923 · MUU
Cytori Therapeutics, Inc.
General & Plastic Surgery · 105d
Cleared Jan 06, 2010
3D ASL
K092925 · LNH
Ge Medical Systems, LLC
Radiology · 105d
Cleared Jan 06, 2010
INTRAX FILM PROCESSOR
K093503 · IXW
Velopex International, Inc.
Radiology · 55d
Cleared Jan 05, 2010
THERMODILUTION CATHETER
K083384 · DQO
Biosensors Intl. Pte. , Ltd.
Cardiovascular · 414d
Cleared Jan 05, 2010
TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
K090312 · GEX
Tria Beauty, Inc.
General & Plastic Surgery · 333d
Cleared Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · LPL
CooperVision, Inc.
Ophthalmic · 244d
Cleared Jan 05, 2010
UNO NARROW IMPLANT
K092555 · DZE
Mis Implants Technologies , Ltd.
Dental · 138d
Cleared Jan 05, 2010
MIKRO-CATH, MODEL 825-0101
K093111 · DXO
Millar Instruments, Inc.
Cardiovascular · 96d
Cleared Jan 05, 2010
FUSION SYSTEM
K093465 · ONF
Eclipsemed Global, Inc.
General & Plastic Surgery · 60d
Cleared Jan 05, 2010
VIVOSIGHT TOPICAL OCT SYSTEM
K093520 · NQQ
Michelson Diagnostics, Ltd.
General & Plastic Surgery · 53d
Cleared Jan 04, 2010
LIGHTWAVE PROFESSIONAL DELUXE
K082586 · GEX
Lightwave Technologies, LLC
General & Plastic Surgery · 483d
Cleared Jan 04, 2010
LUNG FLUTE THERAPEUTIC
K091557 · BWF
Medical Acoustics
Anesthesiology · 222d
Cleared Jan 04, 2010
EXEL I.V. EXTENSION SET
K092172 · FPA
Exelint Intl. Co.
General Hospital · 167d
Cleared Dec 31, 2009
MORPHEUS
K082249 · EJI
Meibach Tech Ltda
Dental · 510d
Cleared Dec 31, 2009
MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES
K091541 · CAW
Sequal Technologies Co., Ltd.
Anesthesiology · 219d
Cleared Dec 31, 2009
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
K093392 · FGE
Navilyst Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 30, 2009
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND...
K090920 · CFN
The Binding Site, Ltd.
Immunology · 273d
Cleared Dec 30, 2009
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM...
K090986 · NDN
Dfine, Inc.
Orthopedic · 267d
Cleared Dec 30, 2009
MEDTRONIC DENTAL TCP
K092087 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 174d
Cleared Dec 30, 2009
ENABLER-P CATHETER SYSTEM, MODEL 3000
K092174 · DQY
Endocross, Ltd.
Cardiovascular · 162d