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
172417–172440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1978
MICRONET LIGHT DRESSING SPONGE
K780408 · NAB
Kendall Research Center
General & Plastic Surgery · 9d
Cleared Mar 21, 1978
TELETRACE TELEPHONE EKG TRANSMITTER
K780158 · DXH
Medtronic Vascular
Cardiovascular · 50d
Cleared Mar 21, 1978
PHONIC EAR
K780363 · ESD
Hc Electronics
Ear, Nose, Throat · 15d
Cleared Mar 21, 1978
CUP, ACETABULAR, LONG POSTERIOR WALL
K780398 · JDI
Orthopedic Equipment Co., Inc.
Orthopedic · 8d
Cleared Mar 17, 1978
CANDIDA IMMUNODIFFUSION KIT
K770527 · GMI
I M, Inc.
Microbiology · 364d
Cleared Mar 17, 1978
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
K772362 · FIE
Terumo America, Inc.
Gastroenterology & Urology · 80d
Cleared Mar 17, 1978
URINE SCREENING KITS
K780021 · JXA
Diagnostic Culture System
Microbiology · 72d
Cleared Mar 17, 1978
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121 · CDX
Syva Co.
Chemistry · 53d
Cleared Mar 17, 1978
NEEDLEHOLDER, MICROVASULAR 5 1/2
K780154 · HNM
Edward Weck, Inc.
Ophthalmic · 46d
Cleared Mar 17, 1978
OXYGEN ANALYZER 110
K780185 · CCC
Siemens Corp.
Anesthesiology · 39d
Cleared Mar 17, 1978
INSERTER, PLUG, BONE, LIDGE
K780283 · LGF
Depuy, Inc.
Orthopedic · 24d
Cleared Mar 17, 1978
LYOPHILIZED VIALS OF VCA AND VCAT
K780306 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Mar 17, 1978
RABBIT ANTIBODY TO DIGOXIN
K780316 · DKA
Pcl-Ria, Inc.
Toxicology · 21d
Cleared Mar 17, 1978
PASSIVE TENDON IMPLANT
K780320 · HXA
Holter-Hausner Intl.
Orthopedic · 21d
Cleared Mar 17, 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · DJB
Kallestad Laboratories, Inc.
Immunology · 18d
Cleared Mar 17, 1978
RID SYSTEM-HUMAN C-REACTIVE PROTEIN
K780325 · DEN
Icl Scientific
Immunology · 18d
Cleared Mar 17, 1978
TOTAL HIP, NEW ENGLAND BAPTIST
K780329 · JDG
Depuy, Inc.
Orthopedic · 18d
Cleared Mar 17, 1978
INSTRUMENT CLEANING BRUSH
K780399 · KDC
Ransom and Randolph
General & Plastic Surgery · 4d
Cleared Mar 15, 1978
DIALYZER, CAPILATORY, HOLLOW FIBER
K772290 · FJI
Redy Laboratories
Gastroenterology & Urology · 93d
Cleared Mar 15, 1978
ULTRASPHYG BLOOD PRESSURE OPTION
K780046 · DXN
Cavitron Corp.
Cardiovascular · 65d
Cleared Mar 15, 1978
FLUORESOFT
K780125 · KYC
Holles Laboratories, Inc.
Ophthalmic · 50d
Cleared Mar 15, 1978
RTV DENTAL SILICONE
K780164 · ELW
Tydont, Inc.
Dental · 43d
Cleared Mar 15, 1978
ORTHODONTIC BRACKET PADS
K780170 · EJF
Rocky Mountain Orthodontics, Inc.
Dental · 41d
Cleared Mar 15, 1978
NAIL, MASSIE II
K780187 · JDO
Howmedica Corp.
Orthopedic · 37d