FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
135553–135576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1988
ACUSON S328 TRANSDUCER
K874028 · IYO
Acuson Computed Sonography
Radiology · 263d
Cleared Jun 21, 1988
ORCEPAD
K875123 · HDD
Alton Dean Medical, Inc.
Obstetrics & Gynecology · 189d
Cleared Jun 21, 1988
OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED
K880820 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 112d
Cleared Jun 21, 1988
XOMED AUDIANT BONE CONDUCTOR
K881382 · LXB
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Jun 21, 1988
BIOPSY GUIDE
K881605 · IYO
Teknar, Inc.
Radiology · 84d
Cleared Jun 21, 1988
CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
K881625 · BZE
Respiratory Care, Inc.
Anesthesiology · 70d
Cleared Jun 21, 1988
AUTOMATIC CALORIC IRRIGATION SYSTEM
K881630 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 21, 1988
SAFETY DRAIN
K881790 · BYH
Ballard Medical Products
Anesthesiology · 56d
Cleared Jun 21, 1988
DENTAL BURS
K882183 · EJL
Tri-Stage, Inc.
Dental · 28d
Cleared Jun 21, 1988
MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
K882210 · BXK
Linde Div. Union Carbide Corp.
Anesthesiology · 26d
Cleared Jun 21, 1988
SULLIVAN NASAL CPAP SYSTEM
K882292 · BYE
Baxter Centre For Medical Research
Anesthesiology · 20d
Cleared Jun 21, 1988
ASEPTIP
K882399 · EKJ
Koppa Innovative Dental Products, Inc.
Dental · 11d
Cleared Jun 20, 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · GEX
Abbott Laboratories
General & Plastic Surgery · 165d
Cleared Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145 · DIF
Bio-Rad
Toxicology · 159d
Cleared Jun 20, 1988
DENVER PLEURO-PERITONEAL SHUNT
K880570 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 131d
Cleared Jun 20, 1988
BARD PCA II INFUSION PUMP
K880733 · FRN
C.R. Bard, Inc.
General Hospital · 117d
Cleared Jun 20, 1988
HEMO SUC NUMBER HS100-HS205
K881036 · GCY
Instrumental Medico Croquevielle S.A.
General & Plastic Surgery · 102d
Cleared Jun 20, 1988
EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
K881116 · KLR
Diagnostic Systems
Toxicology · 97d
Cleared Jun 20, 1988
VASCULAR CLAMP
K881158 · DXC
T. Korossurgical Instruments Corp.
Cardiovascular · 94d
Cleared Jun 20, 1988
CAVITRON ELECTROSURGICAL MODULE (CEM) AND PAK
K881687 · GEI
Cavitron Surgical Systems
General & Plastic Surgery · 62d
Cleared Jun 20, 1988
COLORADO NEEDLE ELECTRODE
K881763 · JOS
Colorado Biomedical, Inc.
General & Plastic Surgery · 56d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991 · DIF
Bio-Rad
Toxicology · 39d