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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171577–171600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 15, 1978
ANTERIORS AND POSTERIORS, PLASTIC
K780217 · ELM
Dentsply Intl.
Dental · 33d
Cleared Mar 15, 1978
BANDAGE SPREADER BLOCK
K780227 · ILZ
Biomet, Inc.
Physical Medicine · 34d
Cleared Mar 15, 1978
PACEMAKER, PROLITH 23U. PULSE GENERATOR
K780238 · DXY
Edwards Pacemaker Systems
Cardiovascular · 30d
Cleared Mar 15, 1978
BRACKET, METAL REINFORCED PLASTIC
K780239 · DYW
Ormco Corp.
Dental · 30d
Cleared Mar 15, 1978
BALLOON PUMP
K780280 · DSP
Datascope Corp.
Cardiovascular · 22d
Cleared Mar 15, 1978
TIBIAL PLATEU
K780284 · MBV
Depuy, Inc.
Orthopedic · 22d