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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115201–115224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1992
BEHRING FIBRINTIMER A
K924124 · JPA
Behring Diagnostics, Inc.
Hematology · 106d
Cleared Dec 01, 1992
HEMOCARD(TM) CONTROL
K924173 · JCM
Isolab, Inc.
Hematology · 104d
Cleared Dec 01, 1992
CLOTTING FACTOR V DEFICIENT PLASMA
K924394 · GJT
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
NEOTHROMITIN(R)
K924395 · GPO
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
CLIBRATION PLASMAS
K924404 · GGN
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
CONTROL PLASMA P
K924405 · GGC
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR
K924545 · GZJ
Mod Mode Medical
Neurology · 84d
Cleared Dec 01, 1992
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
K924843 · LLL
General Biometrics, Inc.
Immunology · 64d
Cleared Dec 01, 1992
FILTERMATE UNIVERSAL HARVESTER
K924907 · JTC
Packard Instrument Co., Inc.
Hematology · 63d
Cleared Nov 30, 1992
ULTRACELL NASAL PACKING
K920358 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 308d
Cleared Nov 30, 1992
AUTOZYME
K922241 · LLL
Cambridge Life Sciences Plc.
Immunology · 201d
Cleared Nov 30, 1992
SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
K922933 · DTZ
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 165d
Cleared Nov 30, 1992
DELFIA HTSH ULTRA KIT
K923401 · JLW
Wallac OY
Chemistry · 143d
Cleared Nov 30, 1992
NUCLEAR MEDICINE LASER IMAGER
K923536 · LMC
General Scanning, Inc.
Radiology · 137d
Cleared Nov 30, 1992
VENTREX ALLERGEN DISC
K924119 · DHB
Ventrex, Inc.
Immunology · 108d
Cleared Nov 30, 1992
VENTREX ALLERGEN DISC
K924209 · DHB
Hycor Biomedical, Inc.
Immunology · 102d
Cleared Nov 30, 1992
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
K924257 · CDZ
Serono-Baker Diagnostics, Inc.
Chemistry · 98d
Cleared Nov 30, 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K924421 · MID
Elias U.S.A., Inc.
Immunology · 90d
Cleared Nov 30, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST
K924500 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 87d
Cleared Nov 30, 1992
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK
K924846 · JTN
Remel Co.
Microbiology · 63d
Cleared Nov 30, 1992
OLYMPUS DIRECT BILIRUBIN REAGENT
K924963 · CIG
Olympus Corp.
Chemistry · 61d
Cleared Nov 30, 1992
VIDAS FREE THYROXINE(FT4) ASSAY
K925177 · CEC
Biomerieux Vitek, Inc.
Chemistry · 47d
Cleared Nov 27, 1992
PULMOCATH INTRABRONCHIAL CATHETER
K901615 · JAQ
Omnitron Intl., Inc.
Radiology · 966d
Cleared Nov 27, 1992
TAHOE SUCTION IRRIGATOR
K911238 · GCX
Tahoe Pro Instruments
General Hospital · 618d