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
166321–166344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1980
MEDEFIZZ A & MEDEFIZZ B
K800843 · KTA
Medefield Pty. , Ltd.
Radiology · 63d
Cleared Jun 17, 1980
BRONZAGE TANNING SYSTEM
K800845
Bronzage Rapide
Radiology · 63d
Cleared Jun 17, 1980
ANESTHESIA EXTENSION TUBES
K800877 · FPK
Harvard Laboratories
General Hospital · 61d
Cleared Jun 17, 1980
SECONDARY I.V. TUBING SETS
K800878 · FPA
Harvard Laboratories
General Hospital · 61d
Cleared Jun 17, 1980
CLEAR PLASTIC CONNECTING TUBES
K800879 · FPK
Harvard Laboratories
General Hospital · 61d
Cleared Jun 17, 1980
TANIT COMMERCIAL SUNTAN BOOTH
K801017 · FTC
Tanit, Inc.
Radiology · 48d
Cleared Jun 17, 1980
ULTRA-CHEK PACEMAKER MONITOR
K801022 · KRE
Powers Medical Systmes
Cardiovascular · 48d
Cleared Jun 17, 1980
3M STEAM STERILIZATION INDICATOR
K801057 · JOJ
3M Company
General Hospital · 42d
Cleared Jun 17, 1980
STRAITH NASAL SPLINT
K801072 · FYI
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared Jun 17, 1980
STRAITH NASAL IMPLANT
K801074 · FZE
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared Jun 17, 1980
F.R.C. APPARATUS
K801088 · BZC
Hogan/Cologne Ent.
Anesthesiology · 40d
Cleared Jun 17, 1980
ANALOR FOUR-ORAL SURGERY MODEL
K801101 · BZE
Narco Mckesson Co.
Anesthesiology · 39d
Cleared Jun 17, 1980
COMPALOR-ORAL SURGERY MODEL
K801102 · BSZ
Narco Mckesson Co.
Anesthesiology · 39d
Cleared Jun 17, 1980
COBAS REAGENT FOR BUN
K801116 · CDQ
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jun 17, 1980
NYLON LIGATING CLIP
K801124 · FZP
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Jun 17, 1980
CENTRIFICHEM HDL CHOLESTEROL
K801133 · LBS
Union Carbide Corp.
Chemistry · 36d
Cleared Jun 17, 1980
EMIT VALPROIC ACID CONTROL
K801206 · LAS
Syva Co.
Toxicology · 29d
Cleared Jun 17, 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · JQP
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Jun 17, 1980
DEN-MAT POLISHING PASTE
K801225 · EJR
Den-Mat Corp.
Dental · 26d
Cleared Jun 17, 1980
HEARING AID, UNITRON MODEL C4-55
K801230 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 17, 1980
JACKSON LACRIMAL INTUBATION SET
K801232 · HNL
Storz Instrument Co.
Ophthalmic · 21d
Cleared Jun 17, 1980
HYDRA TRED DC
K801250 · IOG
Medichanics, Inc.
Physical Medicine · 20d
Cleared Jun 17, 1980
TECNOL QUICK RELEASE LIMB HOLDER
K801272 · FMQ
Tecnol New Jersey Wound Care, Inc.
General Hospital · 20d
Cleared Jun 17, 1980
ACOUSTIC IMPEDANCE METER, MODEL TA-4D
K801293 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 15d