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
70057–70080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Feb 20, 2004
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K040221 · CBK
Maquet Critical Care AB
Anesthesiology · 18d
Cleared Feb 20, 2004
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
K040251 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 17d
Cleared Feb 20, 2004
SINON POWER WHEELCHAIR, SN-W401
K040319 · ITI
Sinon Corporation
Physical Medicine · 11d
Cleared Feb 19, 2004
MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
K032551 · DQA
Masimo Corp.
Anesthesiology · 184d
Cleared Feb 19, 2004
IR FOREHEAD THERMOMETER, MODEL HV-T36
K032612 · FLL
Oriental Inspiration, Ltd.
General Hospital · 178d
Cleared Feb 19, 2004
MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5
K033296 · DQA
Masimo Corp.
Anesthesiology · 128d
Cleared Feb 19, 2004
C2 NASAL MASK
K033759 · BZD
Respironics, Inc.
Anesthesiology · 79d
Cleared Feb 19, 2004
GELSOFT PLUS ERS
K034010 · DSY
Vascutek, Ltd.
Cardiovascular · 57d
Cleared Feb 19, 2004
INTEGRIS 3D-RA, RELEASE 4.2
K040254 · LLZ
Philips Medical Systems North America...
Radiology · 15d
Cleared Feb 18, 2004
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859 · KWD
Arthrosurface, Inc.
Orthopedic · 247d
Cleared Feb 18, 2004
MANOA BREAST BIOPSY SYSTEM
K033205 · GEI
Manoa Medical, Inc.
General & Plastic Surgery · 139d
Cleared Feb 18, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · HAW
Zimmer, Inc.
Neurology · 135d
Cleared Feb 18, 2004
FEMTEC LASER MICROKERATOME
K033354 · GEX
20/10 Perfect Vision Optische Gerate...
General & Plastic Surgery · 121d
Cleared Feb 18, 2004
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
K033517 · MQP
Spinal Concepts, Inc.
Orthopedic · 103d
Cleared Feb 18, 2004
VASCON POLARIS GUIDING CATHETER
K033633 · DQY
Vascon, LLC
Cardiovascular · 91d
Cleared Feb 18, 2004
ADAM
K033978 · GWQ
Astro-Med, Inc.
Neurology · 57d
Cleared Feb 18, 2004
SIS PLASTIC SURGERY MATRIX
K034039 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 51d
Cleared Feb 18, 2004
C.T.M. POWER CHAIR, MODEL HS-1000
K040020 · ITI
C.T.M. Homecare Product, Inc.
Physical Medicine · 43d
Cleared Feb 18, 2004
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
K040104 · GEI
Boston Scientific Corp
General & Plastic Surgery · 29d
Cleared Feb 18, 2004
SANDMAN SD20 AMPLIFIER
K040113 · GWL
Eb Neuro S.P.A.
Neurology · 29d
Cleared Feb 18, 2004
ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
K040139 · KRA
Endobionics, Inc.
Cardiovascular · 27d
Cleared Feb 18, 2004
MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K040150 · DYB
Medamicus, Inc.
Cardiovascular · 26d
Cleared Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
K040167 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d