FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86353–86376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1999
SAS ONE-STEP PREGNANCY
K990741 · JHI
Sa Scientific, Inc.
Chemistry · 63d
Cleared May 10, 1999
ATLAST GLUCOSE CONTROL SOLUTION
K991075 · JJX
Amira Medical, Inc.
Chemistry · 40d
Cleared May 10, 1999
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
K991369 · LCX
Germaine Laboratories, Inc.
Chemistry · 20d
Cleared May 07, 1999
TTCGHI-T AND TTCTN3-T-T
K982451 · KLW
Tinnitus Treatment Centers, Inc.
Ear, Nose, Throat · 296d
Cleared May 07, 1999
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR,...
K983039 · DYB
Schneider/Namic
Cardiovascular · 249d
Cleared May 07, 1999
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND...
K990507 · KPO
Althin Biopharm, Inc.
Gastroenterology & Urology · 78d
Cleared May 07, 1999
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · NFB
Salter Labs
Anesthesiology · 66d
Cleared May 07, 1999
FLOW LINE
K990756 · EBF
Heraeus Kulzer, Inc.
Dental · 60d
Cleared May 07, 1999
STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS...
K991436 · DZE
Sterngold
Dental · 11d
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