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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171121–171144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1978
NEW RESTODENT
K780965 · EBF
Lee Pharmaceuticals
Dental · 10d
Cleared Jun 22, 1978
LEE-ALLOY
K780967 · EJJ
Lee Pharmaceuticals
Dental · 10d
Cleared Jun 22, 1978
CLINICAL ACQUISITION MODULE
K780971 · IYX
Analytical Development Assoc. Corp.
Radiology · 10d
Cleared Jun 22, 1978
SINGLE USE NEEDLE ELECTRODE
K780975 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jun 22, 1978
SINGLE USE BALL ELECTRODE
K780976 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jun 22, 1978
SINGLE USE BLADE ELECTRODE
K780977 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jun 22, 1978
SINGLE USE ACTIVE ELECTRODE HANDLE
K780978 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jun 22, 1978
KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT
K780982 · DDR
Cis Radiopharmaceuticals, Inc.
Immunology · 8d
Cleared Jun 22, 1978
COMPUTERIZED AXIAL TOMOGRAPHY
K780995 · IZF
Emi Medical, Inc.
Radiology · 8d
Cleared Jun 21, 1978
THERA-PAK
K780452 · ILO
Hydro-Med Products, Inc.
Physical Medicine · 92d
Cleared Jun 19, 1978
BIOSTATOR GLUCOSE ANALYZER
K780393 · CGA
Miles Laboratories, Inc.
Hematology · 101d
Cleared Jun 19, 1978
LIQUID CRYSTAL DISPLAY DIGITAL WATCH
K780445 · DRT
Hughes Aircraft Co.
Cardiovascular · 91d
Cleared Jun 19, 1978
CLINICAL GRAPHICS ANALYZER
K780468 · DQK
Numonics Corp.
Cardiovascular · 89d
Cleared Jun 19, 1978
DRAPING MATERIAL, COLBALT 60 STERILE
K780846 · KKX
Kimberly-Clark Corp.
General Hospital · 26d
Cleared Jun 19, 1978
SELF-RETAINING ELECTRODE SER. #4000-100
K780908 · DRX
Andover Medical, Inc.
Cardiovascular · 14d
Cleared Jun 19, 1978
GRAB BAR
K780935 · IKX
Orthopedic Equipment Co., Inc.
Physical Medicine · 12d
Cleared Jun 19, 1978
BLOOD PUMP MODEL 7000
K780942 · DWB
3M Health Care, Sarns
Cardiovascular · 12d
Cleared Jun 14, 1978
NERVE APPROXIMATER
K780289 · GDG
Edward Weck, Inc.
General & Plastic Surgery · 113d
Cleared Jun 14, 1978
CRYOCYTE PACK
K780354 · KSR
Travenol Laboratories, S.A.
Hematology · 103d
Cleared Jun 14, 1978
PODIATRIC MATERIAL
K780391 · MNE
Crown Delta Corp.
Physical Medicine · 96d
Cleared Jun 14, 1978
SPHERISTEM TOTAL HIP PROSTHESIS
K780497 · JDG
American Ortomed Corp.
Orthopedic · 78d
Cleared Jun 14, 1978
L-12, L-21, AND L-22 ELECTRODES
K780569 · DTB
Coratomic, Inc.
Cardiovascular · 64d
Cleared Jun 14, 1978
EXTRACORPEAL CARDIOTOMY BLOOD FILTER
K780653 · JOD
Cobe Laboratories, Inc.
Cardiovascular · 56d
Cleared Jun 14, 1978
B-HCG-RIA
K780679 · JHI
Nuclear Medical Systems, Inc.
Immunology · 51d