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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145033–145056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 204d
Cleared Feb 21, 1986
ALVEO-DIFFUSION TEST
K853443 · BZC
Erich Jaeger, Inc.
Anesthesiology · 189d
Cleared Feb 21, 1986
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
K853876 · HHR
Endo Lase, Inc.
Obstetrics & Gynecology · 157d
Cleared Feb 21, 1986
ENDO-LASE CD40 CO2 FOR GYNECOLOGY
K853903 · HHR
Endo Lase, Inc.
Obstetrics & Gynecology · 154d
Cleared Feb 21, 1986
HOFMANN KNEE
K853991 · JWH
Intermedics Orthopedics
Orthopedic · 147d
Cleared Feb 21, 1986
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · GZJ
Valley Forge Scientific Corp.
Neurology · 147d
Cleared Feb 21, 1986
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · DDG
Abbott Laboratories
Immunology · 109d
Cleared Feb 21, 1986
MEVAMATIC 3
K854609 · JAD
Siemens Medical Laboratories, Inc.
Radiology · 95d
Cleared Feb 21, 1986
CERAPEARL
K854763 · EIH
Kyocera International, Inc.
Dental · 86d
Cleared Feb 21, 1986
FLEX-I-GRASP
K854889 · HRX
Euro-Med Intl.
Orthopedic · 77d
Cleared Feb 21, 1986
IN LINE VALVE CATALOG NO. 2000A
K854965 · FPA
Rao Medical Devices, Inc.
General Hospital · 72d
Cleared Feb 21, 1986
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
K855093 · HHR
Endo Lase, Inc.
Obstetrics & Gynecology · 63d
Cleared Feb 21, 1986
RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR
K855108 · JJQ
Biomaterials International, Inc.
Chemistry · 60d
Cleared Feb 21, 1986
BUNN LITE OXYGEN CONCENTRATOR
K855208 · CAW
The John Bunn Co.
Anesthesiology · 53d
Cleared Feb 21, 1986
PARA-PAK MACRO-CON
K860034 · LKS
Meridian Diagnostics, Inc.
Microbiology · 46d
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 21, 1986
DIRECT BILIRUBIN
K860257 · CIG
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Feb 21, 1986
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326 · KKX
Deroyal Industries, Inc.
General Hospital · 23d
Cleared Feb 21, 1986
BASICAM S COUNTER BALANCE CAMERA
K860454 · IXY
Siemens Gammasonics, Inc.
Radiology · 16d
Cleared Feb 21, 1986
LSP MINILATOR
K860516 · BXY
Life Support Products, Inc.
Anesthesiology · 10d
Cleared Feb 21, 1986
CPRCOACH VOICE PROMPTER & CPR PROMPTER RESCUE AID
K860555
Auralogic
Cardiovascular · 7d
Cleared Feb 21, 1986
SERIES 7050 CAPNOGRAPH
K860556 · CCK
Marquette Electronics, Inc.
Anesthesiology · 7d
Cleared Feb 21, 1986
DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
K860583 · JAY
Dale Medical Products, Inc.
Anesthesiology · 3d
Cleared Feb 20, 1986
INTRACRANIAL PRESSURE MONITORING KIT 070
K853864 · GWM
Camino Laboratories, Inc.
Neurology · 156d