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
116833–116856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1992
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED
K915890 · BTT
Pegasus Research Corp.
Anesthesiology · 183d
Cleared Jun 24, 1992
MAESTRO DIGITAL VIDEO SYSTEM
K920373 · IYO
International Imaging Electronics
Radiology · 147d
Cleared Jun 24, 1992
STATVIEW
K921527 · LMD
Image Data Corp.
Radiology · 82d
Cleared Jun 24, 1992
THYROXINE (FPIA) KIT
K921904 · KLI
Tudor Laboratories, Inc.
Chemistry · 64d
Cleared Jun 24, 1992
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
K922612 · CHH
Cholestech Corp.
Chemistry · 22d
Cleared Jun 23, 1992
TYPE 9050/NEO
K912183 · DPS
S & W Medico Teknik
Cardiovascular · 404d
Cleared Jun 23, 1992
BREATH-EASY, MODIFICATION
K914416 · HME
Icor AB
Ophthalmic · 272d
Cleared Jun 23, 1992
LEVY ARTICULATING RETRACTOR
K920471 · GAD
Lifeguard Medical Products, Inc.
General & Plastic Surgery · 147d
Cleared Jun 23, 1992
DISPOSABLE LATEX EXAMINATION GLOVES
K921438 · LYY
Perlink USA, Inc.
General Hospital · 90d
Cleared Jun 23, 1992
BACTON(TM), AUTO-APO A-1 REAGENT
K921795 · MSJ
Bacton Assay Systems, Inc.
Immunology · 74d
Cleared Jun 23, 1992
NEOPLASTINE CI PLUS
K922040 · GJS
American Bioproducts Co.
Hematology · 53d
Cleared Jun 23, 1992
MODIFIED SITE POWER HANDPIECE
K922077 · EKX
Chiron Vision Corp.
Dental · 50d
Cleared Jun 22, 1992
MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
K913324 · HDB
Neward Enterprises, Inc.
Obstetrics & Gynecology · 333d
Cleared Jun 22, 1992
VITA IN-CERAM
K913644 · EIH
Vident
Dental · 311d
Cleared Jun 22, 1992
DISPOSABLE O.R. TOWEL, STERILE
K915740 · KKX
American Threshold Industries, Inc.
General Hospital · 182d
Cleared Jun 22, 1992
COILS FOR RX4000 & RX5000 MRI SYSTEMS
K920254 · LNH
Resonex, Inc.
Radiology · 153d
Cleared Jun 22, 1992
MODIFIED ORTHO EBV VCA-IGG ELISA
K920412 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 143d
Cleared Jun 22, 1992
IMZ SURGICAL INSTRUMENT TRAY
K921246 · DZE
Interpore Intl.
Dental · 98d
Cleared Jun 22, 1992
MG-1001 TUBE HOUSING ASSEMBLY
K921316 · ITY
Magma Corp.
Radiology · 97d
Cleared Jun 22, 1992
DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
K921479 · EIH
Degussa AG
Dental · 84d
Cleared Jun 22, 1992
JOBST EXTREMITY PUMP SYSTEM 7500
K921562 · JOW
Jobst Institute, Inc.
Cardiovascular · 82d
Cleared Jun 22, 1992
BACTON(TM), AUTO-APO B REAGENT
K921862 · MSJ
Bacton Assay Systems, Inc.
Immunology · 69d
Cleared Jun 19, 1992
TSRH(TM) LATERAL OFFSET PLATE
K914306 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 268d
Cleared Jun 19, 1992
CD2 MONOCLONAL ANTIBODIES
K914846 · GKZ
Gen Trak, Inc.
Hematology · 235d