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
94081–94104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 95d
Cleared May 06, 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
K970454 · HQY
Laxima Intl., Ltd.
Ophthalmic · 90d
Cleared May 06, 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL...
K970463 · DTZ
Terumo Medical Corp.
Cardiovascular · 89d
Cleared May 06, 1997
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
K970476 · HQY
Hwa Mao Optical Co., Ltd.
Ophthalmic · 88d
Cleared May 06, 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · LIT
Cordis Corp.
Cardiovascular · 77d
Cleared May 06, 1997
REUSABLE VITRECTOMY PROBE
K970670 · HQE
Altex Vision
Ophthalmic · 71d
Cleared May 06, 1997
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · HQD
Polymer Technology Corp.
Ophthalmic · 70d
Cleared May 06, 1997
SOLAR SPECS
K970759 · HQY
Morris Rosenbloom & Co., Inc.
Ophthalmic · 64d
Cleared May 06, 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared May 06, 1997
SILOC SYSTEM
K970848 · KLE
Heraeus Kulzer, Inc.
Dental · 60d
Cleared May 06, 1997
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
K970878 · MPA
American Medical Devices, Inc.
Ophthalmic · 57d
Cleared May 06, 1997
CUSTOM OPTICAL SUNGLASS FRAMES
K970895 · HQY
Custom Optical Frames, Inc.
Ophthalmic · 56d
Cleared May 06, 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · LYY
Safeskin Corp.
General Hospital · 56d
Cleared May 06, 1997
SAFE-CONNECT I.V. SET
K970909 · FPA
Faulding Medical Device Co.
General Hospital · 55d
Cleared May 06, 1997
BARAKKA, INFERNO, STERLING, AND/OR ONE
K970944 · HQY
Sentinal Importing Corp.
Ophthalmic · 54d
Cleared May 06, 1997
CLASSIC MATCH
K971104 · HQY
Delagar Division Belcam, Inc.
Ophthalmic · 41d
Cleared May 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
K971108 · MSG
Alexander Mfg. Co.
Ophthalmic · 41d
Cleared May 06, 1997
INSTRUMENT TRAY LINER
K971217 · FSM
General Hospital Supply Corp.
General & Plastic Surgery · 34d
Cleared May 06, 1997
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN
K971249 · HQY
Andrew G. Halpern
Ophthalmic · 33d
Cleared May 06, 1997
ARROW COMPANY
K971326 · HQY
Excel Eyewear Corp.
Ophthalmic · 26d
Cleared May 06, 1997
SYNTEC, INC. DISPOSABLE BARE END FIBER
K971338 · MPA
Syntec, Inc.
Ophthalmic · 26d
Cleared May 06, 1997
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
K971466 · JQB
Carolina Liquid Chemistries Corp.
Chemistry · 14d
Cleared May 05, 1997
CENTAURI
K932683 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 1432d
Cleared May 05, 1997
CENTAURI
K933841 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 1370d