FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68713–68736 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 17, 2004
VECTORVISION CRANIAL/ENT
K023651 · HAW
Brainlab AG
Neurology · 475d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST...
K032903 · DIO
ACON Laboratories, Inc.
Toxicology · 153d
Cleared Feb 17, 2004
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
K032958 · LNS
United Medical Systems, Inc.
Gastroenterology & Urology · 148d
Cleared Feb 17, 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST...
K033047 · DJG
ACON Laboratories, Inc.
Toxicology · 141d
Cleared Feb 17, 2004
ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
K033768 · ILY
Altus Medical, Inc.
Physical Medicine · 76d
Cleared Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · FGE
Abbott Laboratories
Gastroenterology & Urology · 62d
Cleared Feb 17, 2004
QLAB QUANTIFICATION SOFTWARE
K040227 · LLZ
Philips Ultrasound
Radiology · 15d
Cleared Feb 17, 2004
SUPRAFLOW CONSOLE
K040239 · BTA
Neomedix Corp.
General & Plastic Surgery · 15d