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
90001–90024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1998
CMVGEN
K974456 · LJO
Instrumentation Laboratory CO
Microbiology · 157d
Cleared May 01, 1998
BIO-POST DENTAL POST SYSTEM
K974649 · ELR
Advanced Aeromedical, Inc.
Dental · 140d
Cleared May 01, 1998
COAMATIC PLASMINOGEN
K974711 · GGP
Instrumentation Laboratory CO
Hematology · 135d
Cleared May 01, 1998
BACTEC MGIT 960 SYSTEM
K974883 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 122d
Cleared May 01, 1998
BRONCHIAL CATHETER SYSTEM
K980046 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 115d
Cleared May 01, 1998
OAC (OPTICAL ASPIRATING CURETTE)
K980096 · HCY
Imagyn Medical Technologies, Inc.
Obstetrics & Gynecology · 112d
Cleared May 01, 1998
IMMULITE ANTI-TG AB
K980206 · JZO
Diagnostic Products Corp.
Immunology · 101d
Cleared May 01, 1998
TRIP TONOMETRY CATHETER, 18F
K980384 · CCK
Datex-Engstrom, Inc.
Anesthesiology · 88d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR...
K980385 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared May 01, 1998
SOPRANO CRYO-THERAPY SYSTEM
K980393 · GEI
Gynecare Innovation Center
General & Plastic Surgery · 88d
Cleared May 01, 1998
KERATOME BLADE, CHIROM MODEL ALK 500500
K980508 · HNO
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200...
K980510 · HNO
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · LLM
Clark Laboratories, Inc.
Microbiology · 73d
Cleared May 01, 1998
ENDOSOLV E
K980633 · KIF
Specialites Septodont
Dental · 71d
Cleared May 01, 1998
HEELBO WAIST AND CHEST VEST
K980640 · FMQ
Heelbo, Inc.
General Hospital · 71d
Cleared May 01, 1998
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · JHO
Helena Laboratories
Chemistry · 71d
Cleared May 01, 1998
CERA E DENTAL ALLOY
K980661 · EJS
European Dental Imports, Inc.
Dental · 70d
Cleared May 01, 1998
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 67d
Cleared May 01, 1998
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 59d
Cleared May 01, 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · JMM
Diagnostic Products Corp.
Chemistry · 58d
Cleared May 01, 1998
GII SPINAL FIXATION SYSTEM
K980852 · MNH
Karen E. Warden, M.E.B.E.
Orthopedic · 57d
Cleared May 01, 1998
SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
K980965 · ELW
Cavex Holland BV
Dental · 46d
Cleared May 01, 1998
SCMD-1000
K980985 · HNO
Howard Instruments, Inc.
Ophthalmic · 45d
Cleared May 01, 1998
MG
K981192 · JGJ
Abbott Laboratories
Chemistry · 29d