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
56497–56520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2008
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
K080386 · GXY
Columbia Scientific Development, LLC
Neurology · 107d
Cleared May 30, 2008
NANOCOMPOSITE RESTORATIVE KIT
K080480 · EBF
Dmg USA, Inc.
Dental · 98d
Cleared May 30, 2008
SCIENT'X TRIBECA VBR
K080588 · MAX
Scient'X USA, Inc.
Orthopedic · 88d
Cleared May 30, 2008
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
K080763 · DWJ
Talley Medical
Cardiovascular · 73d
Cleared May 30, 2008
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
K081034 · HQD
Synergeyes, Inc.
Ophthalmic · 49d
Cleared May 30, 2008
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND...
K081035 · DSB
Osypka Medical, Inc.
Cardiovascular · 49d
Cleared May 30, 2008
GORE INFINIT MESH
K081069 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 45d
Cleared May 30, 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · NKB
Depuy Spine, Inc.
Orthopedic · 28d
Cleared May 29, 2008
PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
K072290 · BYT
Dima Italia Srl
Anesthesiology · 287d
Cleared May 29, 2008
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
K073006 · GWO
Takiron Co., Ltd.
Neurology · 218d
Cleared May 29, 2008
UREA/BUN, SCAL, NORTROL, ABTROL
K073295 · CDQ
Thermofisher Scientific OY
Chemistry · 188d
Cleared May 29, 2008
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR,...
K080161 · GCJ
Patton Surgical Corp.
General & Plastic Surgery · 127d
Cleared May 29, 2008
LDR SPINE ROI-C IMPLANT
K080728 · MQP
Ldr Spine USA
Orthopedic · 76d
Cleared May 29, 2008
CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
K080860 · MQP
Creaspine
Orthopedic · 63d
Cleared May 29, 2008
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
K080951 · LLZ
Totoku Electric Co., Ltd.
Radiology · 56d
Cleared May 29, 2008
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
K080952 · LLZ
Totoku Electric Co., Ltd.
Radiology · 56d
Cleared May 29, 2008
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
K081102 · GWG
Visionsense, Ltd.
Neurology · 42d
Cleared May 29, 2008
INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
K081194 · OVE
Rsb Spine, LLC
Orthopedic · 31d
Cleared May 29, 2008
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
K081257 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 27d
Cleared May 29, 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278 · KTT
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared May 29, 2008
GENESIS ECP
K081359 · DRN
Scottcare Corporation
Cardiovascular · 14d
Cleared May 29, 2008
PALOMAR ASPIRE LASER PLATFORM
K081416 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 9d
Cleared May 28, 2008
THERABOND ANTIMICROBIAL BARRIER SYSTEMS
K073213 · FRO
Choice Therapeutics
General & Plastic Surgery · 196d
Cleared May 28, 2008
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION...
K073244 · FRC
STERIS Corporation
General Hospital · 191d