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
168505–168528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1979
PIASMA SAFE
K792185 · KSR
Cry-O-Safe, Inc.
Hematology · 58d
Cleared Dec 27, 1979
MODEL 674 PACER ANALYZER
K792074 · DTC
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 448 PACERCORDER
K792076 · DSH
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 449 ELECTROCARDIOCORDER
K792078 · DSH
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 447 ELECTROCARDIOCORDER
K792079 · DSH
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO
K792272 · GEC
Dexide, Inc.
General & Plastic Surgery · 44d
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