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
167665–167688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
K792336 · GGP
Helena Laboratories
Hematology · 38d
Cleared Dec 27, 1979
PENTAX BROCHOFIBERSCOPE MODEL FB-17D,
K792342 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 38d
Cleared Dec 27, 1979
INTRA-ARTICULATED EDGER-PLANER SYSTEM
K792353 · HWE
Richard Wolf Medical Instruments Corp.
Orthopedic · 37d
Cleared Dec 27, 1979
SYSTEM 103 CHEMISTRY ANALYZER
K792361 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 36d
Cleared Dec 27, 1979
CHOCOLATE TELLURITE AGAR
K792424 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 30d
Cleared Dec 27, 1979
DECARBOXYLASE MOELLER BASE WITH OR WITH-
K792425 · JSE
Isle Media and Sterile Products, Inc.
Microbiology · 30d
Cleared Dec 27, 1979
VAGINAL PACKING
K792431 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 29d
Cleared Dec 27, 1979
TSH RADIOIMMUNOASSAY
K792443 · JLW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 27, 1979
NORLAND MODEL 278 BONE DENSITOMETER
K792444 · KGI
Norland Corp.
Radiology · 28d
Cleared Dec 27, 1979
REFEREE BFT BLOOD FOR TONOMETRY
K792447 · JJS
Analytical Products, Inc.
Chemistry · 27d
Cleared Dec 27, 1979
FEEDING TUBE PLACEMENT STYLET
K792468 · FZX
Biosearch Medical Products, Inc.
General & Plastic Surgery · 24d
Cleared Dec 27, 1979
ELECTRO-IMMUNO-QUANTITATION (EIQ)
K792472 · DAK
Icl Scientific
Immunology · 24d
Cleared Dec 27, 1979
CHEM-STRATE CK-NAC
K792477 · CGS
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
CHEM-STRATE CHOLESTEROL
K792478 · CHH
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
CHEM-STRATE AMYLASE
K792479 · CIJ
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
CHEM-STRATE TRIGLYCERIDE
K792480 · CDT
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
TIPSEP-T3U TRIIODOTHYRONINE UPTAKE
K792484 · KHQ
Nuclear Diagnostics, Inc.
Toxicology · 24d
Cleared Dec 27, 1979
RIONET HEARING AID HB-32T
K792505 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 27, 1979
RIONET HEARING AID HB-68L
K792506 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 27, 1979
IREX CARDIOPLAN
K792525 · DQK
Irex Corp.
Cardiovascular · 21d
Cleared Dec 27, 1979
PLAQUE-X DENTURE CLEANER
K792530 · JER
Nexell Corp.
Dental · 20d
Cleared Dec 27, 1979
TRYPTOSE BLOOD AGAR BASE & TRYPTOSE
K792543 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 17d
Cleared Dec 27, 1979
LYSINE IRON AGAR
K792544 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 17d
Cleared Dec 27, 1979
CONTAINER SYSTEM
K792558 · FLE
Aesculap Instruments Corp.
General Hospital · 15d