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
132121–132144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1989
ULTIMA WHEELCHAIR CUSHION
K890653 · IMP
Clark Pillow Co., Inc.
Physical Medicine · 20d
Cleared Feb 28, 1989
BARD UMBILICAL VESSEL CATHETER
K890685 · FOS
C.R. Bard, Inc.
General Hospital · 19d
Cleared Feb 27, 1989
DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)
K883324 · LMC
Siemens Gammasonics, Inc.
Radiology · 206d
Cleared Feb 27, 1989
TORAY FILTRYZER BK SERIES
K883407 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 200d
Cleared Feb 27, 1989
LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT
K884018 · CAW
Lamelli Pulmonary Research Center
Anesthesiology · 158d
Cleared Feb 27, 1989
AMPLAID EMG15
K884071 · GWL
Amplus Corp.
Neurology · 153d
Cleared Feb 27, 1989
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
K884378 · JJE
Coulter Corp.
Chemistry · 132d
Cleared Feb 27, 1989
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
K884555 · JAK
Toshiba Medical Systems
Radiology · 119d
Cleared Feb 27, 1989
ACUFEX FIXATION BUTTON
K884565 · KGS
Acufex Microsurgical, Inc.
General & Plastic Surgery · 118d
Cleared Feb 27, 1989
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
K884753 · CEC
Advanced Magnetics, Inc.
Chemistry · 105d
Cleared Feb 27, 1989
TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
K884788 · JAK
Toshiba Medical Systems
Radiology · 104d
Cleared Feb 27, 1989
BIOTENS
K884814 · GXY
Trekk Intl.
Neurology · 102d
Cleared Feb 27, 1989
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
K884889 · KWL
Protek, Inc.
Orthopedic · 97d
Cleared Feb 27, 1989
BALANCE SYSTEM
K884926 · LXV
Chattanooga Group, Inc.
Ear, Nose, Throat · 91d
Cleared Feb 27, 1989
INFUSA-PLATE(TM) EX
K885083 · FRN
Kalayjian Ent.
General Hospital · 80d
Cleared Feb 27, 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129 · JOH
Bivona Medical Technologies
Anesthesiology · 77d
Cleared Feb 27, 1989
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K885130 · JOH
Bivona Medical Technologies
Anesthesiology · 77d
Cleared Feb 27, 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · KNW
Boston Scientific Corp
Gastroenterology & Urology · 76d
Cleared Feb 27, 1989
ADVANTAGE
K885246 · GWF
Clark Davis Medical Systems, Inc.
Neurology · 67d
Cleared Feb 27, 1989
CALCIUM PLUS PROCEDURE
K890302 · CJY
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Feb 27, 1989
PROTECTOR (SURGICAL INSTRUMENT)
K890314 · MMK
Richard-Allan Medical Ind., Inc.
General Hospital · 35d
Cleared Feb 27, 1989
GLUCOSE (GOD) REAGENT
K890336 · CGA
Alpkem Corp.
Chemistry · 35d
Cleared Feb 27, 1989
LC, CARDIAC POSITIONER #B5078A
K890348 · IZI
General Electric Co.
Radiology · 35d
Cleared Feb 27, 1989
VAGINAL SPECULUM
K890376 · HFD
Kinetic Medical Products
Obstetrics & Gynecology · 35d