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
173713–173736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1977
COMPONENTS, ANKLE, TRIAL, CON-AXIAL
K770421 · HSN
Depuy, Inc.
Orthopedic · 7d
Cleared Mar 14, 1977
PUNCTURE KIT, INTERNAL JUGULAR
K770462 · DQO
Arrow Intl., Inc.
Cardiovascular · 5d
Cleared Mar 10, 1977
SYN-O-SCOPE NASAL INHALER
K760674 · KCO
Mcdonald and Assoc., Inc.
Ear, Nose, Throat · 175d
Cleared Mar 10, 1977
CONVERSE ALTAR RETRACTOR
K760851 · KAL
V. Mueller O.V. Baxter Healthcare Corp.
Ear, Nose, Throat · 146d
Cleared Mar 10, 1977
TUBE HOLDING DEVICE
K770108 · FPK
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 52d
Cleared Mar 10, 1977
SPECTROPHOTOMETERS, INFRARED MODELS X99
K770278 · JJQ
The Perkin-Elmer Corp.
Chemistry · 24d
Cleared Mar 10, 1977
SPECTROPHOTOMETER, MODEL 597 IR
K770288 · JJQ
The Perkin-Elmer Corp.
Chemistry · 24d
Cleared Mar 10, 1977
MONITOR, RADIOISOTOPE, MODEL 9273A
K770397
Amersham Corp.
Radiology · 8d
Cleared Mar 10, 1977
RADIOEAR MODEL 1072
K770402
Radioear Corp.
Gastroenterology & Urology · 7d
Cleared Mar 10, 1977
OVERLOAD WARNING DEVICE
K770405 · IRN
Synthes (Usa)
Physical Medicine · 7d
Cleared Mar 10, 1977
LEAD, HEART, BUTTERFLY CLAMP
K770416 · DTB
Arco Medical Products Co.
Cardiovascular · 6d
Cleared Mar 10, 1977
GAR, COLUMBIA, W/5% HORSE BLOOD
K770441 · JSO
Bd Becton Dickinson Vacutainer...
Microbiology · 3d
Cleared Mar 09, 1977
BAND-AID BRAND OF ADHESIVE BANDAGES
K770081 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 54d
Cleared Mar 09, 1977
PROLITH MODEL 21S CARDIAC PULSE GEN.
K770212 · DXY
Edwards Pacemaker Systems
Cardiovascular · 37d
Cleared Mar 09, 1977
ARGYLE RAPID GASTRIC LAVAGE KIT
K770248 · KDH
Sherwood Medical Industries
Gastroenterology & Urology · 30d
Cleared Mar 09, 1977
ELECTROTHERAPY APPARATUS E.T. 720
K770276 · IPF
Fort & Assoc.
Physical Medicine · 23d
Cleared Mar 09, 1977
MONITOR, FETAL HEART, MODEL 1980
K770292 · HGI
Berkeley Bio-Engineering
Obstetrics & Gynecology · 23d
Cleared Mar 09, 1977
ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
K770295 · HGI
Brattle Instrument Corp.
Obstetrics & Gynecology · 23d
Cleared Mar 09, 1977
FETAL MONITOR, PART #101-11009
K770296 · HGM
Brattle Instrument Corp.
Obstetrics & Gynecology · 23d
Cleared Mar 09, 1977
FETAL MONITOR, PART #100-11009
K770297 · HGM
Brattle Instrument Corp.
Obstetrics & Gynecology · 23d
Cleared Mar 09, 1977
CUTTER, P606 BONE
K770302 · FZT
Dentronix, Inc.
General & Plastic Surgery · 21d
Cleared Mar 09, 1977
NIPPER, NAIL, P610 ENGLISH
K770303 · FZT
Dentronix, Inc.
General & Plastic Surgery · 21d
Cleared Mar 09, 1977
CUTTER, P605 GENERAL PURPOSE
K770304 · FZT
Dentronix, Inc.
General & Plastic Surgery · 21d
Cleared Mar 09, 1977
CUTTER, P607 BONE
K770305 · FZT
Dentronix, Inc.
General & Plastic Surgery · 21d