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
107473–107496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1994
ORTHO TECH CRYOLOGIC SYSTEM
K940429 · ILO
Orthopedic Technology, Inc.
Physical Medicine · 162d
Cleared Jul 12, 1994
CHEN-HERSIN SUNGLASSES
K940488 · HQY
Chen Hersin Ent.
Ophthalmic · 158d
Cleared Jul 12, 1994
AUTO REFF-30
K940516 · HKO
Canon, Inc.
Ophthalmic · 158d
Cleared Jul 12, 1994
CHEN SHUENG ENTERPRISE CO.
K940625 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
CLEVER OPTICAL INDUSTRIES LTD
K940626 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
WENZHOU IMPORT AND EXPORT CORP
K940627 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
JIHN MEI OPTICAL CO.
K940628 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
YEOU NAN SUNGLASSES CO
K940629 · HQY
Sunny Sunglasses
Ophthalmic · 148d
Cleared Jul 12, 1994
THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
K940858 · ILO
Innovation Sports, Inc.
Physical Medicine · 139d
Cleared Jul 12, 1994
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION
K940868 · LIT
Cordis Corp.
Cardiovascular · 140d
Cleared Jul 12, 1994
A-DEC RADIUS 2122/2132
K940893 · EIA
A-Dec, Inc.
Dental · 137d
Cleared Jul 12, 1994
SUNGLASSES
K940924 · HQY
Sunny Sunglasses
Ophthalmic · 134d
Cleared Jul 12, 1994
WESTERN TRADING CO
K941047 · HQY
Eva Optiks, Inc.
Ophthalmic · 127d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES
K941053 · HQY
Hsin Chen Intl. Co., Ltd.
Ophthalmic · 131d
Cleared Jul 12, 1994
GIP/MEDI-GLOBE BIOPSY FORCEPS
K941359 · FCL
Medi-Globe Corp.
Gastroenterology & Urology · 113d
Cleared Jul 12, 1994
EYECOTECH CORP
K941414 · HQZ
Eyecotech Corp.
Ophthalmic · 111d
Cleared Jul 12, 1994
BONE GRAFT DELIVERY SYRINGES
K941431 · EID
Bio-Interfaces, Inc.
Dental · 110d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K941441 · HQY
Sun-Set Enterprise Co. , Ltd.
Ophthalmic · 110d
Cleared Jul 12, 1994
SUNGLASSES
K941538 · HQY
Solar Sunglasses Corp.
Ophthalmic · 104d
Cleared Jul 12, 1994
SUNGLASSES/VARIOUS COLLECTIONS
K941555 · HQY
Atlantic Optical Co., Inc.
Ophthalmic · 103d
Cleared Jul 12, 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847 · LZO
Depuy, Inc.
Orthopedic · 89d
Cleared Jul 12, 1994
SOLUTION HIP
K941942 · LZO
Depuy, Inc.
Orthopedic · 82d
Cleared Jul 12, 1994
INFUSION PUMP, MODEL NO. UDP-5
K942023 · FEN
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 77d
Cleared Jul 12, 1994
PATIENT EXAMINATION GLOVE
K942086 · LYY
Qrp, Inc.
General Hospital · 71d