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
94393–94416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL...
K964863 · EBW
Bell Intl., Inc.
Dental · 86d
Cleared Feb 28, 1997
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
K964876 · FPA
Vlv Associates, Inc.
General Hospital · 85d
Cleared Feb 28, 1997
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
K964888 · DXH
Tz Medical, Inc.
Cardiovascular · 84d
Cleared Feb 28, 1997
HANSSON PIN SYSTEM
K964893 · JDW
Osteonics Corp.
Orthopedic · 84d
Cleared Feb 28, 1997
STRYKER SAPHENOUS VEIN HARVEST SCOPE
K964930 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 81d
Cleared Feb 28, 1997
OSTEONICS SCREW HOLE PLUGS
K965056 · JDK
Osteonics Corp.
Orthopedic · 72d
Cleared Feb 28, 1997
INTRAMEDULLARY NAIL SYSTEM
K965098 · HSB
Zimmer, Inc.
Orthopedic · 70d
Cleared Feb 28, 1997
BIPOLAR SUCTION COAGULATOR
K965241 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 79d
Cleared Feb 28, 1997
MEDNEXT SURGICAL BUR
K970023 · HWE
Mednext, Inc.
Orthopedic · 56d
Cleared Feb 28, 1997
SPINE-TECH BONE HARVESTER
K970040 · HWE
Spine-Tech, Inc.
Orthopedic · 53d
Cleared Feb 28, 1997
HA GLOBAL TAPER (GT) TAPERED HIP STEM
K970337 · MEH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 30d
Cleared Feb 28, 1997
GLOBAL TAPER SPECTRON HIP STEMS
K970351 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 29d
Cleared Feb 27, 1997
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED...
K962666 · FYA
Bemiss-Jason Corp., Triad Medical Div.
General Hospital · 233d
Cleared Feb 27, 1997
BERGEN 610 BIPOLAR COAGULATOR
K964736 · GEI
Bergen Mfg.
General & Plastic Surgery · 94d
Cleared Feb 27, 1997
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
K964845 · LYY
Jinhua Latex Products Factory
General Hospital · 86d
Cleared Feb 27, 1997
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
K964847 · LYY
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 86d
Cleared Feb 27, 1997
MR EXTENSION SET (001)
K964968 · FPA
University of Michigan
General Hospital · 77d
Cleared Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · HWC
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Feb 27, 1997
ARGI-SATIN OR OPTI0-STAR
K965216 · ELL
Argen Precious Metals, Inc.
Dental · 59d
Cleared Feb 27, 1997
3M QUIKPLUS SYSTEM
K970168 · EBG
3M Company
Dental · 42d
Cleared Feb 27, 1997
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
K970567 · KWT
Intermedics Orthopedics
Orthopedic · 14d
Cleared Feb 26, 1997
SHE-LI TENS STIMULATOR MODEL SL-101 RX
K961809 · GZJ
Medi Consultants, Inc.
Neurology · 292d
Cleared Feb 26, 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 288d
Cleared Feb 26, 1997
LIFESHIELD BLUNT CANNULA
K963351 · FMI
Abbott Laboratories
General Hospital · 184d