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
85849–85872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1999
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY...
K991134 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 34d
Cleared May 05, 1999
GAS PLASMA STERILIZATION
K972774 · JWH
Zimmer, Inc.
General Hospital · 650d
Cleared May 05, 1999
CYSTIC DUCT BALLOON DILATING CATHETER
K983154 · FGE
Applied Medical Resources
Gastroenterology & Urology · 238d
Cleared May 05, 1999
LIFEPAK 500 BIPHASIC
K983393 · MKJ
Physio-Control Corp.
Cardiovascular · 222d
Cleared May 05, 1999
SCANFLEX SOLID COUPLANT MEMBRANE
K983691 · ITX
Sonotech, Inc.
Radiology · 197d
Cleared May 05, 1999
CTS-310(B)
K984161 · IYO
Shantou Institute of Ultrasonic...
Radiology · 166d
Cleared May 05, 1999
ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
K984189 · FOZ
Maxxim Medical
General Hospital · 163d
Cleared May 05, 1999
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K984496 · KDQ
Atrium Medical Corp.
General Hospital · 139d
Cleared May 05, 1999
APOLLO 5, APOLLO 10
K990383 · IYE
Precitron A.B.
Radiology · 86d
Cleared May 05, 1999
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
K990701 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 63d
Cleared May 05, 1999
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES
K991085 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 36d
Cleared May 05, 1999
MODIFICATION TO ULTRA-SELECT GUIDEWIRE
K991194 · DQX
Microvena Corp.
Cardiovascular · 27d
Cleared May 05, 1999
FALCON IVF FOUR WELL PLATE
K991249 · MQK
Becton Dickinson Labware
Obstetrics & Gynecology · 22d
Cleared May 05, 1999
FALCON IVF ONE WELL DISH
K991251 · MQK
Becton Dickinson Labware
Obstetrics & Gynecology · 22d
Cleared May 05, 1999
FALCON IVF ROUND DISH
K991253 · MQK
Becton Dickinson Labware
Obstetrics & Gynecology · 22d
Cleared May 04, 1999
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
K983982 · KGO
Maxxim Medical
General Hospital · 176d
Cleared May 04, 1999
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
K984249 · LZA
London International Group, Inc.
General Hospital · 155d
Cleared May 04, 1999
DBC, DONG BANG ACUPUNCTURE NEEDLES
K990328 · MQX
Morning Star, Dong Bang Acupuncture...
General Hospital · 91d
Cleared May 04, 1999
ORALGIENE TONGUE CLEANER
K990344 · LCN
Oralgiene USA, Inc.
Dental · 89d
Cleared May 04, 1999
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990575 · LZA
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990577 · LZA
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990686 · LYY
Tower Rubber Industries Sdn. Bhd.
General Hospital · 62d
Cleared May 04, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
K990695 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 62d
Cleared May 04, 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN...
K990702 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 62d