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
131761–131784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1989
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
K891167 · DLB
Diagnostic Products Corp.
Toxicology · 58d
Cleared May 03, 1989
IQ CALCIUM
K891217 · CIC
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared May 02, 1989
OROSPHERE HCDP
K890681 · EJJ
Jeneric/Pentron, Inc.
Dental · 82d
Cleared May 02, 1989
SIEMENS SIRECUST 730 PATIENT MONITOR
K890791 · DPS
Siemens Medical Electronics
Cardiovascular · 74d
Cleared May 02, 1989
QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
K890998 · IYN
Quantum Medical Systems, Inc.
Radiology · 88d
Cleared May 02, 1989
IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
K891472 · LZV
Implant Technology, Inc.
Orthopedic · 48d
Cleared May 02, 1989
FILAFLEX ORTHODONTIC WIRE
K891599 · EJF
American Orthodontics
Dental · 43d
Cleared May 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891976 · LYY
Ever Surplus (Usa), Inc.
General Hospital · 34d
Cleared May 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891977 · LYY
Grandclass, Ltd.
General Hospital · 34d
Cleared May 02, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891978 · LYY
Latex Supply Products (Hp), Inc.
General Hospital · 34d
Cleared May 02, 1989
PRICHARD PERIOSTEAL RETRACTOR #3
K892260 · EKJ
Zinnanti Surgical Instruments, Inc.
Dental · 28d
Cleared May 01, 1989
BURNEY GALLBLADDER CATHETER KIT
K880343 · FGE
Mallinckrodt Critical Care
Gastroenterology & Urology · 461d
Cleared May 01, 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · DRX
S & W Medico Teknik
Cardiovascular · 153d
Cleared May 01, 1989
HEMATOME SYSTEM
K885066 · GET
Surgical Dynamics, Inc.
General & Plastic Surgery · 146d
Cleared May 01, 1989
ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES
K885166 · DRO
Zmi Corp.
Cardiovascular · 139d
Cleared May 01, 1989
STANDEX
K885343 · ION
Alt, Inc.
Physical Medicine · 124d
Cleared May 01, 1989
ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON
K890143 · NUW
Microcurrent Research, Inc.
Dental · 108d
Cleared May 01, 1989
JASPER JUMPER KIT
K890536 · EJF
American Orthodontics
Dental · 87d
Cleared May 01, 1989
NEW FREEDOM THIN DEODORANT MAXI PADS
K890655 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 82d
Cleared May 01, 1989
SCALP VEIN SET
K890679 · FPA
Ashley Health Care, Inc.
General Hospital · 81d
Cleared May 01, 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
K890808 · DTZ
3M Company
Cardiovascular · 73d
Cleared May 01, 1989
DENTURE RESIN
K890830 · EBI
G-C Intl. Corp.
Dental · 69d
Cleared May 01, 1989
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 69d
Cleared May 01, 1989
MODEL 4041
K890855 · LNH
Medical Advances, Inc.
Radiology · 69d