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
163489–163512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1981
MALE LUER LOCK PLUGS
K810921 · FPA
Procedure Products, Inc.
General Hospital · 45d
Cleared May 21, 1981
SYSTEM 400
K810973 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 41d
Cleared May 21, 1981
PREFILLED PULSATOR SYRINGE
K810995 · FMF
Concord Laboratories, Inc.
General Hospital · 38d
Cleared May 21, 1981
BETA I & BETA II
K811082 · IZL
Porta Ray, Inc.
Radiology · 30d
Cleared May 21, 1981
SUR-FIT DISPOSABLE FANGE CAP
K811163 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 23d
Cleared May 21, 1981
FOCUS STERILE SYRINGES
K811167 · FMF
Stanford Laboratories
General Hospital · 23d
Cleared May 21, 1981
MARZ-175
K811199 · CBT
Emde Corp.
Anesthesiology · 21d
Cleared May 21, 1981
EFTEKHAR ACETABULAR STANDOFF
K811201
Zimmer, Inc.
Orthopedic · 20d
Cleared May 21, 1981
SAF SINGLE-USE AEROSOL FILTER
K811203 · GCY
Sorensen Research
General & Plastic Surgery · 20d
Cleared May 21, 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · DTR
Shiley, Inc.
Cardiovascular · 20d
Cleared May 21, 1981
MOLDED POLYSULFONE TRIAL PROSTHESIS
K811205 · HWT
Shannon Group
Orthopedic · 20d
Cleared May 21, 1981
SELF HEATING DISPOSABLE HEAT PAD
K811206 · IMD
Ensar Corp.
Physical Medicine · 20d
Cleared May 21, 1981
MODEL 1100 SPHYGMOMANOMETER
K811208 · DSK
Y
Cardiovascular · 20d
Cleared May 21, 1981
DIGOXIN (RIA) KIT
K811212 · DNL
Immuno Assay Corp.
Toxicology · 17d
Cleared May 21, 1981
ASSURE NATURAL FIT TAMPON
K811214 · HIL
Personal Products Co.
Obstetrics & Gynecology · 17d
Cleared May 21, 1981
KOVA STRIP 6
K811219 · JIR
Icl Scientific
Microbiology · 17d
Cleared May 21, 1981
INORGANIC PHOSPHORUS REAGENTS
K811222 · CED
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared May 21, 1981
VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223 · KOA
Biomet, Inc.
Gastroenterology & Urology · 17d
Cleared May 21, 1981
DISPOSABLE UNDERPADS
K811232 · KME
Burina
General Hospital · 17d
Cleared May 21, 1981
DISPOSABLE STERILIZATION WRAP
K811242 · FRG
Amsco Co.
General Hospital · 17d
Cleared May 21, 1981
TECHNICON SMAC II SYSTEM & ACCESSORIES
K811249 · JJC
Technicon Instruments Corp.
Chemistry · 16d
Cleared May 21, 1981
CITRATE BUFFER
K811251 · JCC
Bioscientific
Chemistry · 16d
Cleared May 20, 1981
SPENCO DERMAL PADS
K811184 · FMP
Spenco Medical Corp.
General Hospital · 21d
Cleared May 18, 1981
SC/TEMP 300
K810332 · HCC
Thought Technology , Ltd.
Neurology · 98d