FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92425–92448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1997
DISETRONIC PENFINE INJECTION PEN NEEDLE
K973339 · FMI
Disetronic Medical Systems
General Hospital · 19d
Cleared Sep 23, 1997
ANGIOMAT ILLUMENA
K963071 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 412d
Cleared Sep 23, 1997
SHELHIGH PERICARDIAL PATCH
K964467 · DXZ
Shelhigh, Inc.
Cardiovascular · 320d
Cleared Sep 23, 1997
PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND...
K970906 · CBZ
Diametrics Medical, Ltd.
Anesthesiology · 195d
Cleared Sep 23, 1997
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
K971150 · GCJ
Mist, Inc.
General & Plastic Surgery · 179d
Cleared Sep 23, 1997
CAPNOXYGEN MASK
K971229 · CCK
Medsys, Inc.
Anesthesiology · 174d
Cleared Sep 23, 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 23, 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · LZO
Howmedica, Inc.
Orthopedic · 90d
Cleared Sep 23, 1997
IMNET DICOM NETWORK AGENT
K972366 · LMD
Imnet Systems, Inc.
Radiology · 90d
Cleared Sep 23, 1997
FOTONA SKINLIGHT PLUS ND: YAG SYSTEM
K972368 · GEX
Medical Laser Solutions
General & Plastic Surgery · 90d
Cleared Sep 23, 1997
EZ SPRAY
K972397 · CCQ
Intertex Research, Inc.
Anesthesiology · 89d
Cleared Sep 23, 1997
ADVANTAGE WINDOWS VOLUME RENDERING OPTION
K972399 · JAK
Ge Medical Systems, Inc.
Radiology · 89d
Cleared Sep 23, 1997
MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
K972426 · HIH
Imagyn Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Sep 23, 1997
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439 · FFX
Medtronic-Synectics
Gastroenterology & Urology · 85d
Cleared Sep 23, 1997
Z DEQ-II
K973266 · ESD
Electone, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 22, 1997
IMMULITE CEA
K970877 · DHX
Diagnostic Products Corp.
Immunology · 196d
Cleared Sep 22, 1997
ULTRASOUND SYSTEMS DRAPE
K970885 · MMP
Protek Medical Products, Inc.
General Hospital · 195d
Cleared Sep 22, 1997
T1 LINE DENTAL HANDPIECES
K972436 · EFB
Siemens AG
Dental · 84d
Cleared Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972462 · LOJ
Bayer Corp.
Immunology · 83d
Cleared Sep 22, 1997
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972580 · JMM
Bayer Corp.
Chemistry · 74d
Cleared Sep 22, 1997
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · GWN
Ics Medical Corp.
Neurology · 70d
Cleared Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · CGX
Sigma Diagnostics, Inc.
Chemistry · 61d
Cleared Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
K972963 · LCM
Boehringer Mannheim Corp.
Toxicology · 42d
Cleared Sep 22, 1997
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · GIO
Innovative Medical Technologies, Inc.
Hematology · 42d