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

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175,820 results
132241–132264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891416 · LYY
Sampson Development Corp.
General Hospital · 21d
Cleared Apr 04, 1989
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891469 · CKA
Trace Scientific , Ltd.
Chemistry · 20d
Cleared Apr 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891649 · LYY
Lic-Orthion
General Hospital · 18d
Cleared Apr 03, 1989
TECHTON PROTECTIVE PAD
K873038 · IWQ
Techton, Inc.
Radiology · 608d
Cleared Apr 03, 1989
VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV
K880259 · LYN
Colorado Hearing Systems, Inc.
Ear, Nose, Throat · 437d
Cleared Apr 03, 1989
XIMAVIEW(TM)
K884323 · KPQ
Varian Assoc., Inc.
Radiology · 171d
Cleared Apr 03, 1989
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
K884560 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 154d
Cleared Apr 03, 1989
TRAUMAFUSE RAPID INFUSION DEVICE
K890077 · DTN
The Traumafuse Co.
Cardiovascular · 84d
Cleared Apr 03, 1989
NEEDLE GUARD(TM)
K890473 · FMI
Martech Medical Products, Inc.
General Hospital · 62d
Cleared Apr 03, 1989
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K890815 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Apr 03, 1989
RADKOR BS-10 AND BS-10T
K891395 · IXY
Radkor, Inc.
Radiology · 20d
Cleared Mar 31, 1989
Q-PLEX 1
K881235 · BZC
Quinton, Inc.
Anesthesiology · 374d
Cleared Mar 31, 1989
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
K882507 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 287d
Cleared Mar 31, 1989
NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT
K883917 · IYO
Sonomed Technology, Inc.
Radiology · 196d
Cleared Mar 31, 1989
STRETCHER TABLE
K884292 · KXH
Fischer Imaging Corp.
Radiology · 170d
Cleared Mar 31, 1989
MANDIBLE MANIPULATOR
K884308 · EKJ
Leonard Medical, Inc.
Dental · 169d
Cleared Mar 31, 1989
SUPER MAXX OTHERS (MULTIPLE) CONDOMS
K884468 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 157d
Cleared Mar 31, 1989
ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS
K884469 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 157d
Cleared Mar 31, 1989
KIMONO PLUS OTHERS (MULTIPLE) CONDOMS
K884470 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 157d
Cleared Mar 31, 1989
PHYSIOGARD SM 785
K885177 · DPS
Adam
Cardiovascular · 108d
Cleared Mar 31, 1989
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · KLS
Syva Co.
Chemistry · 98d
Cleared Mar 31, 1989
GX-2000 STATIONARY X-RAY GENERATOR
K890083 · IZO
Gendex Corp.
Radiology · 80d
Cleared Mar 31, 1989
CLEARFIL CR INLAY
K890123 · EBF
Kuraray Co.
Dental · 79d
Cleared Mar 31, 1989
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 67d