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
56689–56712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2008
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
K073675 · ILO
Gaymar Industries, Inc.
Physical Medicine · 132d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012 · LSR
Bio-Rad
Microbiology · 126d
Cleared May 08, 2008
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
K080202 · OAB
Oncobionics, Inc.
General & Plastic Surgery · 101d
Cleared May 08, 2008
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K080313 · NKB
Depuy Spine, Inc.
Orthopedic · 92d
Cleared May 08, 2008
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
K080437 · HCG
Micrus Endovascular Corporation
Neurology · 83d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · LPH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared May 08, 2008
PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
K080654 · GCJ
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 62d
Cleared May 08, 2008
LYRIC HEARING AID
K081136 · ESD
Insound Medical, Inc.
Ear, Nose, Throat · 17d
Cleared May 08, 2008
TEMPTOUCH DERMAL THERMOMETER
K081162 · FLL
Diabetica Solutions, Inc.
General Hospital · 14d
Cleared May 07, 2008
PROLYTE ELECTROLYTE ANALYZER
K070104 · JGS
Diamond Diagnostics, Inc.
Chemistry · 483d
Cleared May 07, 2008
REVERA WOUND CARE, MODEL MDW0060
K070463 · FRO
Revalesio Corporation
General & Plastic Surgery · 446d
Cleared May 07, 2008
DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
K072236 · NUC
Ssl Americas
Obstetrics & Gynecology · 271d
Cleared May 07, 2008
ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
K072536 · MRG
Esa Biosciences, Inc.
Chemistry · 243d
Cleared May 07, 2008
OPTISTAR ELITE INJECTION SYSTEM
K073592 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 139d
Cleared May 07, 2008
LDR SPINE ROI-T IMPLANT
K080569 · MQP
Ldr Spine USA
Orthopedic · 68d
Cleared May 07, 2008
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
K080648 · QSY
Ore-Medix, LLC
General & Plastic Surgery · 61d
Cleared May 07, 2008
BIO-CONSOLE 560
K080824 · DWA
Medtronic Perfusion Systems
Cardiovascular · 44d
Cleared May 07, 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
K080988 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared May 07, 2008
U-CLIP UNI-FIRE, MODEL M65
K081082 · FZP
Medtronic, Inc.
General & Plastic Surgery · 21d
Cleared May 06, 2008
OPHTHALMOSCOPE F-10
K072259 · MYC
Nidek Co., Ltd.
Ophthalmic · 266d
Cleared May 06, 2008
HEPATOSTAT SET
K073493 · GAM
Vygon Corp.
General & Plastic Surgery · 146d
Cleared May 06, 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · MQV
Novabone Products, LLC
Orthopedic · 124d
Cleared May 06, 2008
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
K080050 · FED
Spirus Medical, Inc.
Gastroenterology & Urology · 119d
Cleared May 06, 2008
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
K080397 · NHA
American Dental Implant Corporation
Dental · 83d