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

Filters: Cleared only ×
176,076 results
79537–79560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2001
MEDCOMP ASH SPLIT
K011576 · NFK
Medical Components, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 21, 2001
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR...
K011593 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 28d
Cleared Jun 21, 2001
INDUO BLOOD GLUCOSE METER
K011616 · NBW
Inverness Medical Innovations, Inc.
Chemistry · 27d
Cleared Jun 20, 2001
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
K010406 · FOZ
Jms Co., Ltd.
General Hospital · 128d
Cleared Jun 20, 2001
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
K010410 · FOZ
Jms Co., Ltd.
General Hospital · 128d
Cleared Jun 20, 2001
BIOSCANNER CREATININE TEST STRIPS
K010456 · JFY
Polymer Technology Systems, Inc.
Chemistry · 124d
Cleared Jun 20, 2001
NTI TENSION SUPPRESSION SYSTEM
K010876 · OCO
Nti-Tss, Inc.
Dental · 89d
Cleared Jun 20, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM
K010884 · HWC
Anchor Medical Technologies
Orthopedic · 89d
Cleared Jun 20, 2001
PTW DOSIMETRY DIODE, T60008
K010916 · IYE
Ptw-New York Corp.
Radiology · 85d
Cleared Jun 20, 2001
SEALAPEX 4
K010940 · KIF
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · DJG
Microgenics Corp.
Toxicology · 65d
Cleared Jun 20, 2001
THIN FILM DRESSING FOR ULTRASOUND EXAM
K011284 · ITX
Martin E. Wendelken
General & Plastic Surgery · 54d
Cleared Jun 20, 2001
ZIEHM VISION
K011292 · OWB
Ziehm International, Inc.
Radiology · 51d
Cleared Jun 20, 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
K011297 · FOZ
Nipro Medical Corp.
General Hospital · 51d
Cleared Jun 20, 2001
Q-RAD RADIOGRAPHIC SYSTEM
K011486 · KPR
Quantum Medical Imaging, LLC
Radiology · 36d
Cleared Jun 20, 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · NBW
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Jun 19, 2001
PFC SIGMA LUGGED TIBIAL TRAY
K003026 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 264d
Cleared Jun 19, 2001
K'FIX
K010847 · NDL
Avanta Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 19, 2001
MERIDIAN-PORTABLE
K010897 · GZO
Meridian Co., Ltd.
Neurology · 85d
Cleared Jun 19, 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
K010901 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 85d
Cleared Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
K010902 · HPZ
Porex Surgical, Inc.
Ophthalmic · 85d
Cleared Jun 19, 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
PROLITE VL PULSED LIGHT SYSTEM
K010928 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d