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
107401–107424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264 · EOQ
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 124d
Cleared Jul 18, 1994
SIMPLA S4, S5, S7
K941447 · KNX
Simpla Plastics , Ltd.
Gastroenterology & Urology · 116d
Cleared Jul 18, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · DIS
Schiapparelli Biosystems, Inc.
Chemistry · 112d
Cleared Jul 18, 1994
NERVE FIBER ANALYZER
K941705 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 103d
Cleared Jul 18, 1994
CHLAMYDIA TRACHOMATIS ANTIGEN TEST
K941714 · LJP
Neogenex
Microbiology · 117d
Cleared Jul 18, 1994
360 DEG. ROTATING 1/2 BEAM BLOCK
K941719 · IXI
Medtec, Inc.
Radiology · 102d
Cleared Jul 18, 1994
MEDICAM 900 REMOTE
K941773 · GCJ
M.P. Video, Inc.
General & Plastic Surgery · 98d
Cleared Jul 18, 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Jul 18, 1994
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K942120 · IZI
GE Medical Systems
Radiology · 76d
Cleared Jul 18, 1994
MED-TEC BREAST SUPPORT SYSTEM
K942282 · IYE
Medtec, Inc.
Radiology · 68d
Cleared Jul 18, 1994
COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
K942573 · FED
Richard Hamer Assoc., Inc.
Gastroenterology & Urology · 48d
Cleared Jul 18, 1994
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
K942749 · ESD
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 38d
Cleared Jul 18, 1994
IMPLANTECH DORSAL NASAL IMPLANT
K942876 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 31d
Cleared Jul 15, 1994
MICROPHOR
K913601 · EGJ
Life-Tech Intl., Inc.
Physical Medicine · 1067d
Cleared Jul 15, 1994
DUPEL IONTOPHORESIS DEVICE
K915444 · EGJ
Empi
Physical Medicine · 953d
Cleared Jul 15, 1994
PACING LEAD MODEL 1188T
K925038 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 648d
Cleared Jul 15, 1994
ARTHROSTIM MANIPULATOR
K930431 · LXM
Freeman Procedure Seminars
Physical Medicine · 535d
Cleared Jul 15, 1994
NON-PRESCRIPTION SUNGLASSES
K936072 · HQY
King'S Sunglass Corp.
Ophthalmic · 207d
Cleared Jul 15, 1994
NIDEK MODEL VT-4000, MODIFICATION
K936302 · HQE
Nidek, Inc.
Ophthalmic · 198d
Cleared Jul 15, 1994
RETURN PATH DIATHERMY HANDLE
K941495 · HQR
Mira, Inc.
Ophthalmic · 109d
Cleared Jul 15, 1994
U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES
K942119 · HQY
U-Top Enterprise Co., Ltd.
Ophthalmic · 73d
Cleared Jul 15, 1994
SEIKO EYEGLASS FRAME
K942513 · HQZ
Seiko Optical Products of America, Inc.
Ophthalmic · 50d
Cleared Jul 15, 1994
SURGI-WIPE
K942642 · HOZ
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 42d
Cleared Jul 15, 1994
NON-PRESCRIPTION SUNGLASSES
K942783 · HQY
Sunpoint Import Co., Inc.
Ophthalmic · 31d