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
109849–109872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1994
SPECTACLE FRAMES
K935968 · HQZ
Sae Biang Optical Co.
Ophthalmic · 71d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K935969 · HQY
Tae Kyung Optical Co., Inc.
Ophthalmic · 71d
Cleared Feb 22, 1994
R&D BATTERIES # 5615, 5234, 5097
K935988 · HLI
R & D Batteries, Inc.
Ophthalmic · 70d
Cleared Feb 22, 1994
OPTICAL FRAMES
K936004 · HQZ
Europa Continental, Inc.
Ophthalmic · 69d
Cleared Feb 22, 1994
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018 · HLJ
R & D Batteries, Inc.
Ophthalmic · 68d
Cleared Feb 22, 1994
SUNGLASSES
K936033 · HQY
Tung Fang Mei Shieh Co., Ltd.
Ophthalmic · 67d
Cleared Feb 22, 1994
ACE UNILATERAL FIXATOR II
K936045 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 64d
Cleared Feb 22, 1994
R & D BATTERIES
K936104 · HLJ
R & D Batteries, Inc.
Ophthalmic · 62d
Cleared Feb 22, 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · JEC
Howmedica, Inc.
Orthopedic · 61d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K936146 · HQY
Franel Optical
Ophthalmic · 57d
Cleared Feb 22, 1994
ELITE COLLECTION
K936149 · HQZ
Omega Group, Inc.
Ophthalmic · 57d
Cleared Feb 22, 1994
EYEGLASS FRAMES
K936217 · HQZ
Ocean Optical Co., Inc.
Ophthalmic · 56d
Cleared Feb 22, 1994
SEE MONSTERS SUNGLASSES
K936218 · HQY
Doppler, Inc.
Ophthalmic · 57d
Cleared Feb 22, 1994
TAVA K-WIRE
K940109 · HTY
Tava Surgical Instruments
Orthopedic · 43d
Cleared Feb 22, 1994
EYEGLASS FRAME
K940113 · HQZ
Wan Wing Optical Co.
Ophthalmic · 43d
Cleared Feb 22, 1994
PRESTIGE FRAMES
K940201 · HQZ
Eye Think Eyewear
Ophthalmic · 40d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K940202 · HQZ
Sam Chung Optical Co., Ltd.
Ophthalmic · 40d
Cleared Feb 22, 1994
STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF
K940214 · DXQ
Statcorp, Inc.
Cardiovascular · 39d
Cleared Feb 22, 1994
SAFE CONNECTOR
K940296 · FPA
Icu Medical, Inc.
General Hospital · 32d
Cleared Feb 22, 1994
NETOH ENDOTRACHEAL TUBE HOLDER
K940448 · CBH
Medical Accessory Services, Inc.
Anesthesiology · 21d
Cleared Feb 19, 1994
ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
K934549 · IWR
Victoreen, Inc.
Radiology · 150d
Cleared Feb 18, 1994
DENVER(R) PERITONEO-SUBCLAVIAN SHUNT
K913728 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 913d
Cleared Feb 18, 1994
HEMOCOR HP HEMOCONCENTRATOR SERIES
K923139 · KDI
Minntech Corp.
Gastroenterology & Urology · 599d
Cleared Feb 18, 1994
HIGH PERMEABILITY DIALYER
K923312 · KDI
Minntech Corp.
Gastroenterology & Urology · 591d