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
170137–170160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1978
CATHETER, USCI GRUNTZIG/BALLOON
K782071 · DYG
C.R. Bard, Inc.
Cardiovascular · 2d
Cleared Dec 14, 1978
AIRFLOMETER
K780894 · BZG
Glaxo Australia Ply. , Ltd.
Anesthesiology · 202d
Cleared Dec 14, 1978
STIMULATOR, MODEL 7727
K782075 · GZJ
Medtronic Vascular
Neurology · 1d
Cleared Dec 13, 1978
VENTILATOR, MINILUNG
K781160 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 161d
Cleared Dec 13, 1978
TRANSMITTER, MODEL 9406 AND 9401
K781986 · DXH
Medtronic Vascular
Cardiovascular · 19d
Cleared Dec 13, 1978
SPIROCARE 108-B
K782016 · BWF
Marion Laboratories, Inc.
Anesthesiology · 8d
Cleared Dec 12, 1978
VENTILATOR, PRESSURE
K781159 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 160d
Cleared Dec 12, 1978
MODEL IV 1500 STANDARD BURETTE
K781637 · FPA
Valleylab, Inc.
General Hospital · 82d
Cleared Dec 12, 1978
DEFIBRILLATOR, MARK II
K781678 · LDD
Ipco Corp.
Cardiovascular · 71d
Cleared Dec 12, 1978
MONITOR/MINI SCOPE
K781679 · DPS
Ipco Corp.
Cardiovascular · 71d
Cleared Dec 12, 1978
ADAPTER, C/D SUCTION
K781713 · BTR
Novametrix Medical Systems, Inc.
Anesthesiology · 67d
Cleared Dec 12, 1978
IRRIGATION TRAY
K781748 · EYN
Intermed, Inc.
General & Plastic Surgery · 56d
Cleared Dec 12, 1978
ADAPTER, CATHETER SHEATH
K781846 · KGZ
Arrow Intl., Inc.
General & Plastic Surgery · 41d
Cleared Dec 12, 1978
9100 DAYSTAR AND 9110 ORBITER PACKAGE
K781887 · FSY
Castle Co.
General & Plastic Surgery · 35d
Cleared Dec 12, 1978
COMPRESSION DEVICES, LIMB
K781964 · IRP
Alba-Waldensian, Inc.
Physical Medicine · 22d
Cleared Dec 12, 1978
PUNCTURE KIT, DISPOSALBE VEIN
K781978 · FMF
Arrow Intl., Inc.
General Hospital · 15d
Cleared Dec 12, 1978
SUCTION APPARATUS, POWERED BY COMP. AIR
K781988 · GCX
Farley, W.T.
General Hospital · 15d
Cleared Dec 12, 1978
FLAT SILICONE DRAIN
K782026 · GCY
Davol, Inc.
General & Plastic Surgery · 7d
Cleared Dec 11, 1978
RESPIRATOR, BANTAM MODEL
K781161 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 159d
Cleared Dec 11, 1978
PULSE GENERATOR, MODEL 240, EXTERNAL
K781327 · DTE
Intermedics, Inc.
Cardiovascular · 132d
Cleared Dec 11, 1978
TRAY, ARTERIAL BLOOD GAS SAMPLING
K781857 · CBT
Jelco Laboratories
Anesthesiology · 35d
Cleared Dec 08, 1978
OMNI STIK
K781616 · CBT
Unitron Corp.
Anesthesiology · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS SA, 350, SAM 500
K781619 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS, MDM 1060, MDM 1090
K781620 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d