FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
104041–104064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1995
ELECTRODES
K944992 · JOS
Linvatec Corp.
General & Plastic Surgery · 197d
Cleared Apr 27, 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · FYA
Standard Textile Co., Inc.
General Hospital · 176d
Cleared Apr 27, 1995
IMX(R) TOXO IGM
K945634 · LGD
Abbott Laboratories
Microbiology · 162d
Cleared Apr 27, 1995
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
K946060 · KKX
Remington Medical, Inc.
General Hospital · 146d
Cleared Apr 27, 1995
BARD FLEXIBLE TIP URETERAL CATHETER
K950300 · EYB
C.R. Bard, Inc.
Gastroenterology & Urology · 92d
Cleared Apr 27, 1995
MOYCO-EDTA
K950365 · KJJ
Union Broach, Div. Moyco Industries,...
Dental · 86d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Apr 27, 1995
BLL-FIL 6140 PARTICLES
K950511 · LYC
Bio-Interfaces, Inc.
Dental · 80d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 80d
Cleared Apr 27, 1995
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700 · ODD
C.R. Bard, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 27, 1995
10.5MM REPLICA HIP STEM
K951095 · LPH
Depuy, Inc.
Orthopedic · 50d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
K951378 · ESD
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
K951379 · ESD
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 27, 1995
VILA PC
K951380 · DYH
Health-Dent Intl., Inc.
Dental · 31d
Cleared Apr 27, 1995
VILA
K951381 · DYH
Health-Dent Intl., Inc.
Dental · 31d
Cleared Apr 27, 1995
VENTIMASK MK IV
K951652 · BYF
Flexicare Medical, Ltd.
Anesthesiology · 17d
Cleared Apr 26, 1995
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
K932530 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 708d
Cleared Apr 26, 1995
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
K932531 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 708d
Cleared Apr 26, 1995
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
K932532 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 708d
Cleared Apr 26, 1995
OMNI-TRAC MODIFICATION
K935020 · MLD
Invivo Research, Inc.
Cardiovascular · 553d
Cleared Apr 26, 1995
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 511d
Cleared Apr 26, 1995
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
K941713 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 419d
Cleared Apr 26, 1995
NOVOPEN 1.5
K942159 · FMF
Novo Nordisk Pharmaceuticals, Inc.
General Hospital · 358d
Cleared Apr 26, 1995
VANTAGE, FOR ADAC GAMMA CAMERAS
K943596 · KPS
Adac Laboratories
Radiology · 275d