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
129313–129336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1989
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894613 · JOH
Bivona Medical Technologies
Anesthesiology · 85d
Cleared Oct 13, 1989
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614 · JOH
Bivona Medical Technologies
Anesthesiology · 85d
Cleared Oct 13, 1989
EMERSON 33-CR CHEST RESPIRATOR
K894649 · BYT
Emerson Intl. Co.
Anesthesiology · 81d
Cleared Oct 13, 1989
LASER SHIELDING TUBE
K894669 · BTR
Vitaid, Ltd.
Anesthesiology · 81d
Cleared Oct 13, 1989
MEDIZIV EPIDURAL SYSTEMS
K894725 · CAZ
Mediziv Medical Devices, Ltd.
Anesthesiology · 80d
Cleared Oct 13, 1989
ALLPAC(TM) MATERIAL
K894759 · EIA
Barrier Concepts, Inc.
Dental · 78d
Cleared Oct 13, 1989
MYODAC2 BIOFEEDBACK DEVICE
K894840 · HCC
Thought Technology , Ltd.
Neurology · 85d
Cleared Oct 13, 1989
SRI 100 RADIOTHERAPY IMAGING SYSTEM
K894912 · IYE
Philips Medical Systems, Inc.
Radiology · 72d
Cleared Oct 13, 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993 · CDP
Baxter Healthcare Corp
Toxicology · 66d
Cleared Oct 13, 1989
CONNELL-STEPHENS ENDO ANESS TUBE
K895132 · BTR
The Traumafuse Co.
Anesthesiology · 57d
Cleared Oct 13, 1989
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
K895169 · BTM
F.L.W. Plastics, Inc.
Anesthesiology · 64d
Cleared Oct 13, 1989
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
K895431 · KMK
Johnson & Johnson Patient Care, Inc.
General Hospital · 37d
Cleared Oct 13, 1989
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS
K895486 · CBK
Percussionaire Corp.
Anesthesiology · 32d
Cleared Oct 13, 1989
SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES
K895604 · GXY
Medical Design & Manufacturing Corp.
Neurology · 25d
Cleared Oct 13, 1989
STERILE SURGICAL GOWN
K895667 · FYE
Clinitech, Inc.
General & Plastic Surgery · 23d
Cleared Oct 13, 1989
HANAULUX(R) 2000
K895715 · FTD
W.C. Heraeus GmbH
General & Plastic Surgery · 18d
Cleared Oct 13, 1989
CITREX LATEX EXAMINATION GLOVES
K895722 · LYY
Pt Citra Latex Lestari
General Hospital · 18d
Cleared Oct 13, 1989
MICROMEDICS SURGICAL DRILL SYSTEM
K895739 · HBB
Micromedics, Inc.
Neurology · 17d
Cleared Oct 13, 1989
LATEX PATIENT EXAMINATION GLOVES
K895743 · LYY
Rubbertech Industry Co., Ltd.
General Hospital · 17d
Cleared Oct 12, 1989
ULTRANS DISPOSABLE INTRAUTERINE
K882224 · HFN
Telos Medical Corp.
Obstetrics & Gynecology · 504d
Cleared Oct 12, 1989
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 227d
Cleared Oct 12, 1989
FEM-FLEX FEMORAL ACCESS CANNULATION SET
K891576 · DWF
Research Medical, Inc.
Cardiovascular · 206d
Cleared Oct 12, 1989
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K891786 · DWP
Pioneering Technologies, Inc.
Cardiovascular · 202d
Cleared Oct 12, 1989
AMPLAID A308 CLINICAL AUDIOMETER
K891988 · EWO
Amplus Corp.
Ear, Nose, Throat · 198d