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
78697–78720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2001
CLEARFIL AP-X
K012740 · EBF
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
TEETHMATE F-1
K012742 · EBC
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
K012743 · DRY
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · DPT
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · MLD
Datex-Ohmeda
Cardiovascular · 22d
Cleared Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · FPA
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Sep 13, 2001
COLORMATE TLC BILITEST SYSTEM
K001687 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 469d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · NBW
Medline Industries, Inc.
Chemistry · 143d
Cleared Sep 13, 2001
OTO-CEM
K011338 · NEA
Ototech, Inc.
Ear, Nose, Throat · 134d
Cleared Sep 13, 2001
MX8000 IDT CT SYSTEM
K012009 · JAK
Marconi Medical Systems, Inc.
Radiology · 78d
Cleared Sep 13, 2001
AQUARIUSNET SERVER
K012086 · LLZ
Terarecon,Inc.
Radiology · 72d
Cleared Sep 13, 2001
ESTENIA
K012707 · EBF
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
CLEARFIL REPAIR
K012729 · KLE
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
CLEARFIL PORCELAIN BOND ACTIVATOR
K012730 · KLE
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174,...
K012871 · KWP
Interpore Cross Intl.
Orthopedic · 17d
Cleared Sep 12, 2001
VECTORVISION HIP
K010602 · HAW
Brainlab AG
Neurology · 196d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · HSB
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 12, 2001
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL...
K011918 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 84d
Cleared Sep 12, 2001
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · HQD
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · DTE
Pace Medical
Cardiovascular · 79d
Cleared Sep 12, 2001
ANCHOR GUIDE LESION LOCALIZATION DEVICE
K012023 · KNW
Senorx, Inc.
Gastroenterology & Urology · 76d
Cleared Sep 12, 2001
ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
K012116 · FRO
Acrymed, Inc.
General & Plastic Surgery · 68d
Cleared Sep 12, 2001
GLUCOMETER DEX TEST SENSOR
K012205 · NBW
Bayer Corp.
Chemistry · 58d
Cleared Sep 12, 2001
MEDFUSION 2001 & 2010, MODEL N7215IWC
K012259 · MRZ
National Custom Ent., Inc.
General Hospital · 56d