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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104401–104424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1995
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
K932690 · JWH
Exactech, Inc.
Orthopedic · 616d
Cleared Feb 09, 1995
ACUFEX TAG ANCHOR
K934867 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 485d
Cleared Feb 09, 1995
MINIMUFFS
K935160 · EWE
Natus Medical, Inc.
Ear, Nose, Throat · 468d
Cleared Feb 09, 1995
VIVALINK AED DEFIBRILLATOR
K940445 · MKJ
Survivalink Corp.
Cardiovascular · 373d
Cleared Feb 09, 1995
HMT ALEXCOPE
K941013 · FGB
Servicetrends, Inc.
Gastroenterology & Urology · 343d
Cleared Feb 09, 1995
OGDEN ANCHOR-SMALL (TENTATIVE)
K941029 · JDR
American Medical Electronics, Inc.
Orthopedic · 339d
Cleared Feb 09, 1995
THE NOMOS CRANE
K941927 · JAI
Nomos Corp.
Radiology · 295d
Cleared Feb 09, 1995
NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
K942580 · IZD
Neoprobe Corp.
Radiology · 254d
Cleared Feb 09, 1995
POET IQ WITH FIVE AGENT CAPABILITY
K942737 · CBS
Criticare Systems, Inc.
Anesthesiology · 244d
Cleared Feb 09, 1995
VANGUARD SERIES GAS REGULATORS
K942751 · CAN
Buckman Co., Inc.
Anesthesiology · 244d
Cleared Feb 09, 1995
TOTALLY COOL(TM) TC-2
K942882 · ILO
Electro Science Technologies, Inc.
Physical Medicine · 237d
Cleared Feb 09, 1995
REMOTE CONTROL RADIOISOTOPE APPLICATOR
K943109 · JAQ
Inter-Pal GmbH
Radiology · 225d
Cleared Feb 09, 1995
LIBERTY
K943250 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 218d
Cleared Feb 09, 1995
ISOLA ANTERIOR SYSTEM
K943819 · KWQ
Acromed Corp.
Orthopedic · 188d
Cleared Feb 09, 1995
TOTALLY COOL(TM) TC-1
K943844 · ILO
Electro Science Technologies, Inc.
Physical Medicine · 237d
Cleared Feb 09, 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K944064 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 174d
Cleared Feb 09, 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K944154 · HEB
Playtex Products, Inc.
Obstetrics & Gynecology · 174d
Cleared Feb 09, 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K944155 · HEB
Playtex Products, Inc.
Obstetrics & Gynecology · 174d
Cleared Feb 09, 1995
COOL/HEAT THERAPY APPLICATOR
K944447 · ILO
Medical Science Technology, Inc.
Physical Medicine · 150d
Cleared Feb 09, 1995
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
K944862 · KNF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 129d
Cleared Feb 09, 1995
EBICE
K945067 · ILO
Electro-Biology, Inc.
Physical Medicine · 118d
Cleared Feb 09, 1995
ALLEVYN ADHESIVE
K945330 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 100d
Cleared Feb 09, 1995
ANGIO II
K945397 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 98d
Cleared Feb 09, 1995
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
K945495 · EXY
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 93d