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

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176,076 results
55537–55560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2008
T12S TELEMETRY TRANSMITTER
K081800 · DQA
Mortara Instrument, Inc.
Anesthesiology · 91d
Cleared Sep 24, 2008
ACCELL TBM-R
K081817 · MBP
Isotis Orthobiologics, Inc.
Orthopedic · 90d
Cleared Sep 24, 2008
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
K081883 · MNH
Us Spine
Orthopedic · 84d
Cleared Sep 24, 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070 · KWQ
Nuvasive, Inc.
Orthopedic · 64d
Cleared Sep 24, 2008
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE,...
K082491 · MTJ
Ceremed , Inc.
General & Plastic Surgery · 27d
Cleared Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · DQO
Terumo Medical Corp.
Cardiovascular · 6d
Cleared Sep 23, 2008
HYGEIA-5 OXYGEN CONCENTRATOR
K081267 · CAW
Kedl Internation Limited
Anesthesiology · 141d
Cleared Sep 23, 2008
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K081443 · HQD
Menicon Co, Ltd.
Ophthalmic · 124d
Cleared Sep 23, 2008
SMARTPORT CT VORTEX
K081472 · LJT
AngioDynamics, Inc.
General Hospital · 119d
Cleared Sep 23, 2008
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
K081904 · LJS
Medcomp
General Hospital · 82d
Cleared Sep 23, 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 29d
Cleared Sep 23, 2008
ULTRAEXTEND USWS-900A
K082596 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Sep 22, 2008
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
K080803 · HQC
American Optisurgical, Inc.
Ophthalmic · 185d
Cleared Sep 22, 2008
UNIVATION UNICONDYLAR KNEE SYSTEM
K081293 · HRY
Aesculap Implant Systems, Inc.
Orthopedic · 138d
Cleared Sep 22, 2008
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL...
K081514 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 115d
Cleared Sep 22, 2008
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
K081743 · CBK
Draeger Medical AG & Co. KG
Anesthesiology · 95d
Cleared Sep 22, 2008
PLANISIGHT LINASYS
K082228 · LLZ
Pathfinder Therapeutics, Inc.
Radiology · 46d
Cleared Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT...
K082645 · NBC
Siemens Healthcare Diagnostics
Chemistry · 11d
Cleared Sep 19, 2008
LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY...
K073498 · GEI
Rudolf Medical GmbH + Co. KG
General & Plastic Surgery · 281d
Cleared Sep 19, 2008
DIZZYFIX
K081602 · LXV
Clearwater Clinical Limited
Ear, Nose, Throat · 105d
Cleared Sep 19, 2008
ICSI CUMULASE
K081639 · MQL
Medicult A/S
Obstetrics & Gynecology · 100d
Cleared Sep 19, 2008
MDI MII ONE-PIECE IMPLANT, 2.9MM
K081653 · DZE
Imtec Corp.
Dental · 99d
Cleared Sep 19, 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730 · ODP
Alphatec Spine, Inc.
Orthopedic · 93d
Cleared Sep 19, 2008
GOLOX-93
K081779 · BYJ
Respironics, Inc.
Anesthesiology · 88d