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
91057–91080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
K974383 · JJX
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 08, 1997
ELECSYS CALCHECK FOLATE
K974384 · JJY
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 08, 1997
MULTI
K974414 · HQY
Morning Calm Corp.
Ophthalmic · 14d
Cleared Dec 05, 1997
ACIST ANGIOGRAPHIC INJECTOR
K963982 · DXT
Invasatec
Cardiovascular · 429d
Cleared Dec 05, 1997
MERIDIAN TITANIUM FEMORAL STEMS
K972228 · LZO
Howmedica, Inc.
Orthopedic · 175d
Cleared Dec 05, 1997
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
K972790 · MSV
Theratest Laboratories, Inc.
Immunology · 130d
Cleared Dec 05, 1997
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION...
K972925 · LMD
Access Radiology Corp.
Radiology · 119d
Cleared Dec 05, 1997
ADVANTAGE 3000
K973355 · IKN
Advantage Medical Division of Cme...
Neurology · 88d
Cleared Dec 05, 1997
ETHICON NON-STICK BIPOLAR FORCEPS
K973384 · GEI
Ethicon, Inc.
General & Plastic Surgery · 88d
Cleared Dec 05, 1997
OVAL SHAPES
K973385 · HXA
Technical Products, Inc.
Orthopedic · 88d
Cleared Dec 05, 1997
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR...
K973421 · LMD
Dejarnette Research Systems
Radiology · 86d
Cleared Dec 05, 1997
STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT
K973423 · DZE
Steri-Oss, Inc.
Dental · 86d
Cleared Dec 05, 1997
STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT
K973433 · DZE
Steri-Oss, Inc.
Dental · 86d
Cleared Dec 05, 1997
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K973616 · MMI
Bayer Corp.
Chemistry · 73d
Cleared Dec 05, 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K973630 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Dec 05, 1997
CARBON FIBER CONFORMAL COUCH TOP
K973842 · IXQ
Medtec, Inc.
Radiology · 58d
Cleared Dec 05, 1997
EL-B2GP1SCR
K973882 · MSV
Theratest Laboratories, Inc.
Immunology · 52d
Cleared Dec 05, 1997
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
K974003 · CKA
Diagnostic Chemicals , Ltd.
Chemistry · 45d
Cleared Dec 05, 1997
ACCUWELL PHENYLALANINE ASSAY
K974047 · JNB
Neometrics, Inc.
Chemistry · 42d
Cleared Dec 04, 1997
VAPOPHENE
K961289 · MED
Germiphene Corp.
General Hospital · 609d
Cleared Dec 04, 1997
POWDER-FREE EXAM GLOVES
K970773 · LYY
Pt. Sarana Indoprotex
General Hospital · 275d
Cleared Dec 04, 1997
PERSONAL INFUSOR
K971362 · MEB
Science Incorporated
General Hospital · 237d
Cleared Dec 04, 1997
RHYTHMSTAT XL
K971650 · DXH
Data Critical Corp.
Cardiovascular · 212d