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
131185–131208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 01, 1989
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · DWF
Shiley, Inc.
Cardiovascular · 63d
Cleared May 01, 1989
NON-STERILE GAUZE SPONGE
K891054 · KHR
Dispomed, Inc.
Dental · 63d
Cleared May 01, 1989
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
K891140 · EBC
Coe Laboratories, Inc.
Dental · 59d
Cleared May 01, 1989
GENERAL ELECTRIC AMX II
K891142 · IZL
Pro-Tronics, Inc.
Radiology · 59d
Cleared May 01, 1989
MICROTRAK EIA AUTOWASHER
K891269 · JYC
Syva Co.
Microbiology · 53d
Cleared May 01, 1989
INSERTION TOOLS
K891617 · DZE
Implant Innovations International, Inc.
Dental · 42d
Cleared May 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891735 · LYY
Harry Panzer Intl. Corp.
General Hospital · 40d
Cleared May 01, 1989
GENETIC SYSTEMS PIPETTOR/DILUTOR
K891765 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K891766 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
GENETIC SYSTEMS MICROPLATE WASHER
K891768 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892011 · LYY
Mediglove Sdn. Bhd.
General Hospital · 32d
Cleared May 01, 1989
PATIENT EXAM GLOVES (MFG. TAN CHONG RUBBER GLOVES)
K892030 · LYY
Behn Meyer & Co. (M) Sdn Bhd
General Hospital · 31d
Cleared May 01, 1989
DENTAL ROOT ELEVATOR
K892255 · EKO
Zinnanti Surgical Instruments, Inc.
Dental · 27d
Cleared May 01, 1989
SLT CONTACT LASER SYSTEMS (GYNECOLOGY)
K892346 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 26d