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
93577–93600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 05, 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · OCV
Olympus America, Inc.
Gastroenterology & Urology · 486d
Cleared May 05, 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
K963054 · LJZ
Genbio
Microbiology · 272d
Cleared May 05, 1997
O'REGAN LIGATOR
K963166 · FHN
Patrick J. O'Regan
Gastroenterology & Urology · 264d
Cleared May 05, 1997
PRESS-FIT HIP STEM
K964178 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 199d
Cleared May 05, 1997
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
K964625 · DSY
Intervascular, Inc.
Cardiovascular · 171d
Cleared May 05, 1997
SHADOWFORM
K964972 · KPQ
I.Z.I. Medical Products Corp.
Radiology · 144d
Cleared May 05, 1997
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
K965045 · HET
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 139d
Cleared May 05, 1997
VIDAS ROTAVIRUS ASSAY
K965092 · LIQ
Biomerieux Vitek, Inc.
Microbiology · 137d
Cleared May 05, 1997
BEHRING COAGULATION SYSTEM
K970431 · JPA
Behring Diagnostics, Inc.
Hematology · 90d