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
114481–114504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1993
ELBOW CPM ORTHOSIS
K925043 · BXB
Electrobionics Corp.
Physical Medicine · 130d
Cleared Feb 12, 1993
FOLDING, WHEELCHAIR
K925146 · IOR
Brownstone Trading Co.
Physical Medicine · 122d
Cleared Feb 12, 1993
AUTO SUTURE SURGICAL MESH DEPLOYER
K925148 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 122d
Cleared Feb 12, 1993
KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR
K925198 · GCJ
Pilling Co.
General & Plastic Surgery · 119d
Cleared Feb 12, 1993
STONEHEART ROLLER AID
K925247 · INM
Stoneheart, Inc.
Physical Medicine · 119d
Cleared Feb 12, 1993
PEDIATRIC TILT CHAIR
K925272 · IOR
Labac Systems, Inc.
Physical Medicine · 116d
Cleared Feb 12, 1993
VALU-PLUS PAD
K925336 · KNN
Valmed, Inc.
Physical Medicine · 113d
Cleared Feb 12, 1993
OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP
K925372 · JWH
Osteonics Corp.
Orthopedic · 112d
Cleared Feb 12, 1993
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 112d
Cleared Feb 12, 1993
UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
K925486 · ITX
Aloka Co., Ltd.
Radiology · 105d
Cleared Feb 12, 1993
VIDAS ESTRADIOL (E2) ASSAY
K925498 · CHP
Biomerieux Vitek, Inc.
Chemistry · 105d
Cleared Feb 12, 1993
CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
K925512 · LZO
Dow Corning Wright
Orthopedic · 210d
Cleared Feb 12, 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · JFL
Hichem Diagnostics
Chemistry · 101d
Cleared Feb 12, 1993
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553 · JFL
Hichem Diagnostics
Chemistry · 101d
Cleared Feb 12, 1993
MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE
K925594 · INQ
Tri W-G, Inc.
Physical Medicine · 99d
Cleared Feb 12, 1993
SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.
K925646 · IYO
Aloka Co., Ltd.
Radiology · 95d
Cleared Feb 12, 1993
SCHNEIDER HYDRO-SIL GUIDEWIRE
K925804 · DQX
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Feb 12, 1993
WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM
K925829 · EIA
Waggoner Dental Mfg.
Dental · 88d
Cleared Feb 12, 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · DQX
Cordis Corp.
Cardiovascular · 88d
Cleared Feb 12, 1993
PRESSURE TURING AND ACCESSORIES
K925918 · GCM
Applied Medical Resources
Gastroenterology & Urology · 81d
Cleared Feb 12, 1993
ADAMS SCIENTIFIC SENSITIVITY DISCS
K925969 · JTN
Adams Scientific, Inc.
Microbiology · 79d
Cleared Feb 12, 1993
SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI
K926013 · LRJ
Sporicidin Intl.
General Hospital · 80d
Cleared Feb 12, 1993
SYNCHRON CX5CE CLINICAL ANALYZER
K926060 · JJE
Beckman Instruments, Inc.
Chemistry · 73d
Cleared Feb 12, 1993
NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES
K926083 · IYX
Biodan Medical Systems, Ltd.
Radiology · 73d