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
171289–171312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1978
GENERATORS, ATRIAL INHIBITED PULSE
K780327 · DXY
Medtronic Vascular
Cardiovascular · 80d
Cleared May 18, 1978
EPILATION TYPE DEVICE
K780348 · KCX
Mehl, Thomas L.
General & Plastic Surgery · 77d
Cleared May 18, 1978
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557 · CGN
Bd Becton Dickinson Vacutainer...
Immunology · 43d
Cleared May 18, 1978
SINGLE VIAL 10 SGOT-TRIS
K780634 · CIT
Boehringer Mannheim Corp.
Toxicology · 31d
Cleared May 18, 1978
SINGLE VIAL 10 SGPT-TRIS
K780636 · CKA
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 18, 1978
LAS-R HUMAN COMPLEMENT CLQ TEST
K780729 · DAK
Hyland Therapeutic Div., Travenol...
Immunology · 16d
Cleared May 17, 1978
CONTACT LENS REMOVER AND INSERTER
K780663 · KYE
Dmv Contact Lens Co.
Ophthalmic · 27d
Cleared May 17, 1978
SOFT LENS REMOVER/INSERTER/MANIPULATOR
K780664 · KYE
Dmv Contact Lens Co.
Ophthalmic · 27d
Cleared May 17, 1978
4600 RECORDER
K780677 · DSF
G & W Applied Science Laboratories
Cardiovascular · 23d
Cleared May 17, 1978
KERR DISCOVERY DISPOSABLE FLUORIDE TRAY
K780712 · KMT
Kerr Corporation (Danbury)
Dental · 21d
Cleared May 16, 1978
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780381 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 67d
Cleared May 16, 1978
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780385 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 67d
Cleared May 16, 1978
BETA CAP SYSTEM
K780449 · FJS
Quinton, Inc.
Gastroenterology & Urology · 57d
Cleared May 16, 1978
ILEX STOMA SEAL AND PROTECTIVE CREAM
K780473 · EXB
Virgil Pichierri
Gastroenterology & Urology · 53d
Cleared May 16, 1978
VAS APPROXIMATOR
K780520 · HAO
Edward Weck, Inc.
Neurology · 46d
Cleared May 16, 1978
PULMONARY FUNCTION TESTER
K780584 · BTY
Warren E. Collins, Inc.
Anesthesiology · 35d
Cleared May 16, 1978
MICROCLIP, WILLIAMS
K780586 · GDW
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 34d
Cleared May 16, 1978
CENTRAL CATHETER KIT
K780673 · FPK
Argon Medical Corp.
General Hospital · 22d
Cleared May 16, 1978
DENTAL OFFICE ENVIRONMENT CONTROL UNIT
K780701 · EHZ
Laminaire Corp.
Dental · 20d
Cleared May 16, 1978
SPEECH AUDIOMETER RA 226
K780749 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared May 16, 1978
ENTRAX TRACTION UNIT
K780763 · HSR
Orthopedic Equipment Co., Inc.
Orthopedic · 8d
Cleared May 16, 1978
MICRO RASPS
K780771 · HTR
Amsco Co.
General & Plastic Surgery · 11d
Cleared May 16, 1978
BAGS, PLASTIC, STERILE FOR GENERATORS
K780777 · DXY
Telectronics, Inc.
Cardiovascular · 12d
Cleared May 12, 1978
TOTAL HIP, LORD MADREPORIC
K780330 · KWA
Howmedica Corp.
Orthopedic · 73d