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

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174,955 results
97801–97824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 42d
Cleared May 15, 1996
BEC NEEDLELESS INJECTION SITE
K961327 · FPA
Biological & Environmental Control...
General Hospital · 37d
Cleared May 15, 1996
INJECTION GOLD PROBE
K961349 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 37d
Cleared May 15, 1996
HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010
K961492 · GCJ
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 27d
Cleared May 14, 1996
TOXOSTAT
K944867 · LGD
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 595d
Cleared May 14, 1996
POLY/PLATINUM WIRE PISTON
K945105 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 574d
Cleared May 14, 1996
PORTABLE ENDOSCOPY SYSTEM
K950712 · GCM
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 455d
Cleared May 14, 1996
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
K951877 · KQO
Chimera Research & Chemical, Inc.
Chemistry · 403d
Cleared May 14, 1996
HOSPITAL LAUNDRY SERVICES SURGICAL PACKS
K953083 · LRO
Hospital Laundry Services
General & Plastic Surgery · 316d
Cleared May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · LFX
Abbott Laboratories
Microbiology · 242d
Cleared May 14, 1996
NEOLON NEOPRENE SURGICAL GLOVES
K954325 · KGO
Maxxim Medical
General Hospital · 242d
Cleared May 14, 1996
IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
K955379 · DRY
International Biophysics Corp.
Cardiovascular · 172d
Cleared May 14, 1996
IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
K955380 · DRY
International Biophysics Corp.
Cardiovascular · 172d
Cleared May 14, 1996
A.S.D. SAFETY TROCAR
K955412 · HET
American Surgical Devices
Obstetrics & Gynecology · 169d
Cleared May 14, 1996
VIFS
K955583 · JAK
Konica Medical Corp.
Radiology · 161d
Cleared May 14, 1996
DRUGBOX
K955659 · LGZ
C.F. Electronics, Inc.
General Hospital · 154d
Cleared May 14, 1996
ABUTMENT SELECTION KIT
K960639 · DZE
Nobelpharma USA, Inc.
Dental · 90d
Cleared May 14, 1996
LASER FIBER DELIVERY/CLEANING CATHETER
K960768 · GEX
Cook Urological, Inc.
General & Plastic Surgery · 78d
Cleared May 14, 1996
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787 · LJH
Baxter Healthcare Corp
Gastroenterology & Urology · 78d
Cleared May 14, 1996
FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG...
K960867 · GEX
B.V. Intl. S.A.
General & Plastic Surgery · 71d
Cleared May 14, 1996
KARL STORZ INTUBATION FIBERSCOPE
K961178 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared May 14, 1996
CLARITY
K961670 · ESD
Seig Technologies, Inc.
Ear, Nose, Throat · 14d
Cleared May 13, 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
K950568 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 460d
Cleared May 13, 1996
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950625 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 458d