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
52825–52848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2009
H-WAVE SPORT
K081998 · NGX
Electronic Waveform Laboratory, Inc.
Physical Medicine · 360d
Cleared Jul 09, 2009
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
K082871 · MSS
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 283d
Cleared Jul 09, 2009
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
K083130 · NQL
Perkinelmer, Inc.
Chemistry · 259d
Cleared CT Jul 09, 2009
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · LPN
Allergan, Inc.
Ophthalmic · 199d
Cleared Jul 09, 2009
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20...
K090165 · DQA
Masimo Corporation
Anesthesiology · 168d
Cleared Jul 09, 2009
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044 · KWQ
Spinal USA
Orthopedic · 87d
Cleared Jul 09, 2009
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
K091057 · DQA
Masimo Corporation
Anesthesiology · 87d
Cleared Jul 09, 2009
XPERT C. DIFFICILE
K091109 · LLH
Cepheid
Microbiology · 84d
Cleared Jul 09, 2009
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
K091219 · NKB
Allez Spine, LLC
Orthopedic · 73d
Cleared Jul 09, 2009
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
K091224 · MUD
Somanetics Corp.
Cardiovascular · 73d
Cleared Jul 09, 2009
ALARIS PC UNIT, MODELS 8000 AND 8015
K091308 · FRN
Cardinal Health 303,Inc.
General Hospital · 66d
Cleared Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 52d
Cleared Jul 09, 2009
EASY.TOUCH INSULIN SYRINGE
K091474 · FMF
Masters Healthcare, LLC
General Hospital · 52d
Cleared Jul 09, 2009
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM
K091515 · GCJ
Novadaq Technologies, Inc.
General & Plastic Surgery · 48d
Cleared Jul 09, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K091523 · LYZ
Shijiazhuang Century Plastic Co., Ltd.
General Hospital · 48d
Cleared Jul 09, 2009
AIRCAST VENAFLOW ELITE SYSTEM
K091700 · JOW
Djo, LLC
Cardiovascular · 29d
Cleared Jul 09, 2009
AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
K091793 · DQY
Aga Medical Corp.
Cardiovascular · 22d
Cleared Jul 09, 2009
LITHO LASER SYSTEM
K091909 · GEX
Quanta System Spa
General & Plastic Surgery · 14d
Cleared Jul 09, 2009
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K091941 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 9d
Cleared Jul 08, 2009
ONCE-A-DAY VERTOS TEST PACK
K082620 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 302d
Cleared Jul 08, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · MNI
Alphatec Spine, Inc.
Orthopedic · 76d
Cleared Jul 08, 2009
ECSCOPE 200
K091397 · DPS
Dyansys, Inc.
Cardiovascular · 57d
Cleared Jul 08, 2009
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
K091431 · LYZ
Zibo Yusheng Plastic Products Co., Ltd.
General Hospital · 56d
Cleared Jul 08, 2009
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 28d