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
97321–97344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1996
DANESHVAR'S DEVICE (MODIFICATION)
K961461 · DXC
Y. Daneshvar
Cardiovascular · 85d
Cleared Jun 26, 1996
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
K961494 · EGS
Micro-Mega Societe Anonyme
Dental · 69d
Cleared Jun 26, 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK...
K961495 · FPA
Baxter Healthcare Corp
General Hospital · 69d
Cleared Jun 26, 1996
VIVAGLASS FIL
K961910 · EMA
Ivoclar North America, Inc.
Dental · 40d
Cleared Jun 26, 1996
QUICKSPLINT
K961995 · EBI
Heraeus Kulzer, Inc.
Dental · 36d
Cleared Jun 26, 1996
MPM HYDROGEL DRESSING (NON-STERILE)
K962160 · MGQ
Mpm Medical., Inc.
General & Plastic Surgery · 22d
Cleared Jun 26, 1996
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
K962165 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jun 26, 1996
VITROS SPECIALTY DILUENT
K962235 · JJE
Johnson & Johnson Clinical...
Chemistry · 15d
Cleared Jun 26, 1996
VIVAGLASS CEM
K962297 · EMA
Ivoclar North America, Inc.
Dental · 40d
Cleared Jun 25, 1996
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
K953948 · BZG
Futuremed America, Inc.
Anesthesiology · 314d
Cleared Jun 25, 1996
HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM
K955853 · JOW
Healthcare Service and Supply
Cardiovascular · 187d
Cleared Jun 25, 1996
BOSWORTH TEMPORARY RESIN
K961199 · EBG
Harry J. Bosworth Co.
Dental · 90d
Cleared Jun 25, 1996
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
K961390 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 76d
Cleared Jun 25, 1996
CIBA CORNING 400 SYSTEM
K961657 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Jun 25, 1996
GE STERILE ARTHROGRAM TRAY
K962035 · FMI
GE Medical Systems
General Hospital · 32d
Cleared Jun 25, 1996
RNS ARTHROGRAM TRAY
K962040 · FMI
Contour Fabricators of Florida, Inc.
General Hospital · 32d
Cleared Jun 24, 1996
LAMINOSS DENTAL IMPLANT
K933705 · DZE
Impladent , Ltd.
Dental · 1060d
Cleared Jun 24, 1996
STERILIZATION
K943657 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 698d
Cleared Jun 24, 1996
PANASIL IMPRESSION MATERIAL
K954281 · ELW
Roydent Dental Products, Inc.
Dental · 285d
Cleared Jun 24, 1996
BIODATA TESTOSTERONE MAIA KIT
K955102 · CDZ
Biochem Immunosystems (U.S.), Inc.
Chemistry · 229d
Cleared Jun 24, 1996
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · LIP
Pyramid Biological Corp.
Microbiology · 80d
Cleared Jun 24, 1996
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 62d
Cleared Jun 24, 1996
DALL-MILES STAINLESS STEEL BEADED CABLE
K961569 · JDQ
Howmedica Corp.
Orthopedic · 62d
Cleared Jun 24, 1996
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
K961570 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 62d