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
136585–136608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1988
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
K875199 · DTB
Biotronik Sales, Inc.
Cardiovascular · 62d
Cleared Feb 18, 1988
SONOLINE CF
K875272 · DXK
Siemens Medical Laboratories, Inc.
Cardiovascular · 56d
Cleared Feb 18, 1988
MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
K875325 · DQO
Schneider-Shilley (Usa)
Cardiovascular · 51d
Cleared Feb 18, 1988
MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER
K875326 · DQO
Schneider-Shilley (Usa)
Cardiovascular · 51d
Cleared Feb 18, 1988
TOWNLEY COX COMB ACETABULAR CUP
K880004 · JDI
Orthomet, Inc.
Orthopedic · 45d
Cleared Feb 18, 1988
HIP, FEMUR AND HUMERUS RETRACTOR
K880151 · GAD
Twenty-First Century Orthopedics, Inc.
General & Plastic Surgery · 36d
Cleared Feb 18, 1988
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
K880166 · LFL
Clinical Technology Corp.
General & Plastic Surgery · 35d
Cleared Feb 18, 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · LBR
Tech-Co, Inc.
Chemistry · 34d
Cleared Feb 18, 1988
CREATINE KINASE (COLORIMETRIC METHOD)
K880178 · JHY
Tech-Co, Inc.
Chemistry · 34d
Cleared Feb 18, 1988
TSRH H/M TORQUE LIMITING WRENCH
K880214 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 30d
Cleared Feb 18, 1988
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
K880215 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 30d
Cleared Feb 18, 1988
ARTHROBOT(TM) LOWER LIMB POSITIONER
K880227 · FQO
Andronic Devices, Ltd.
General & Plastic Surgery · 29d
Cleared Feb 18, 1988
WEHBE ARM HOLDER
K880265 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 27d
Cleared Feb 18, 1988
MULTI-ENZYME LINEARITY SOLUTION
K880266 · JJT
Verichem Laboratories, Inc.
Chemistry · 27d
Cleared Feb 18, 1988
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
K880282 · JEC
Lima-Lto, Inc.
Orthopedic · 28d
Cleared Feb 18, 1988
HOOK PUNCH FORCEPS FOR ARTHROSCOPY
K880331 · HRX
Kibbutz Gilgal Medical C/O Toam...
Orthopedic · 23d
Cleared Feb 18, 1988
SILASTIC NASAL IMPLANT S-TYPE
K880405 · FZE
Dow Corning Wright
General & Plastic Surgery · 20d
Cleared Feb 18, 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436 · GQN
Syva Co.
Microbiology · 16d
Cleared Feb 18, 1988
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
K880441 · FTY
Plane Iii, Inc.
General & Plastic Surgery · 16d
Cleared Feb 17, 1988
ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
K873331 · HRX
Directed Energy, Inc.
Orthopedic · 182d
Cleared Feb 17, 1988
RRT TOTAL IGE TEST KIT
K874541 · DGC
Incstar Corp.
Immunology · 106d
Cleared Feb 17, 1988
SPECTRON EF ACETABULAR COMPONENT
K874619 · JDI
Richards Medical Co., Inc.
Orthopedic · 100d
Cleared Feb 17, 1988
PERMCATH INSERTION TRAY
K874633 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 100d
Cleared Feb 17, 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d