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
131641–131664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1989
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN
K890431 · GCX
Deknatel, Inc.
General Hospital · 67d
Cleared Apr 04, 1989
GIARDEIA(TM)
K890774 · KHW
Antibodies, Inc.
Microbiology · 48d
Cleared Apr 04, 1989
TROJAN FOR WOMEN
K890863 · HIS
Armkel, LLC
Obstetrics & Gynecology · 42d
Cleared Apr 04, 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · CGA
Heraeus Kulzer, Inc.
Chemistry · 42d
Cleared Apr 04, 1989
BUTTERFLY GLOBE (PATIENT EXAMINATION GLOVE)
K890982 · LYY
O.L. Trading, Inc.
General Hospital · 36d
Cleared Apr 04, 1989
LINISTAIN SLS
K890984 · KIO
Shandon, Inc.
Pathology · 36d
Cleared Apr 04, 1989
VINYL PATIENT EXAMINATION GLOVE
K890986 · LYZ
Precious Mountain Ent. Corp.
General Hospital · 34d
Cleared Apr 04, 1989
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · CIG
Catachem, Inc.
Chemistry · 35d
Cleared Apr 04, 1989
STERILE PATIENT EXAMINATION GLOVES
K891329 · LYY
Galaxy Intl., Inc.
General Hospital · 40d
Cleared Apr 04, 1989
NON-STERILE PATIENT EXAMINATION GLOVES
K891330 · LYY
Galaxy Intl., Inc.
General Hospital · 40d
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