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
132193–132216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079 · LDD
Physio-Control Corp.
Cardiovascular · 50d
Cleared Feb 23, 1989
SAFEPETTE DISPENSER
K890109 · JKA
Safe-Tec Clinical Products, Inc.
Chemistry · 44d
Cleared Feb 23, 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · NFB
Salter Labs
Anesthesiology · 35d
Cleared Feb 23, 1989
DELFIA PROGESTERONE KIT
K890428 · JLS
Pharmacia, Inc.
Chemistry · 28d
Cleared Feb 23, 1989
HEMORRHAGE OCCLUDOR
K890447 · GDW
Surgeon Surgical Instrumentation, Inc.
General & Plastic Surgery · 27d
Cleared Feb 23, 1989
CARDIOBEEPER IV
K890461 · DXH
Survival Technology, Inc.
Cardiovascular · 24d
Cleared Feb 23, 1989
SURGICAL GOWNS
K890474 · FYA
Victoria Slipper Retail & Mfg., Co.
General Hospital · 23d
Cleared Feb 23, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
K890561 · CFQ
Atlantic Antibodies
Immunology · 30d
Cleared Feb 22, 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · EWO
Resound Corp.
Ear, Nose, Throat · 149d
Cleared Feb 22, 1989
SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
K884159 · DYB
Mallinckroot, Inc.
Cardiovascular · 141d
Cleared Feb 22, 1989
POLYGLUCOSE POWDER
K884422 · FRO
Anthony N Silvetti, M.D., S.C.
General & Plastic Surgery · 123d
Cleared Feb 22, 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · DQR
Daig Corp.
Cardiovascular · 120d
Cleared Feb 22, 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · DYB
Daig Corp.
Cardiovascular · 120d
Cleared Feb 22, 1989
ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS
K884811 · DTB
Telectronics and Control Pacing Systems
Cardiovascular · 97d
Cleared Feb 22, 1989
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
K884871 · ESD
Resound Corp.
Ear, Nose, Throat · 93d
Cleared Feb 22, 1989
SOLARETTES
K884878 · HQY
Dioptics
Ophthalmic · 93d
Cleared Feb 22, 1989
INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
K885154 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 69d
Cleared Feb 22, 1989
CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
K885238 · CAZ
The Kendal Co.
Anesthesiology · 63d
Cleared Feb 22, 1989
COULTER FLOW RETICULOCYTE REAGENT
K885332 · GKL
Coulter Electronics, Inc.
Hematology · 56d
Cleared Feb 22, 1989
MULTISKOP
K890352 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 22, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
K890416 · DEW
Atlantic Antibodies
Immunology · 29d
Cleared Feb 22, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
K890562 · DAD
Atlantic Antibodies
Immunology · 29d
Cleared Feb 22, 1989
VITALON CHAIR MASSAGER MODEL V-CHR2
K890643 · ISA
Nexus Co. , Ltd. C/O Yama Trans Co. ,...
Physical Medicine · 14d
Cleared Feb 17, 1989
PHADEBACT SHIGELLA TEST
K880752 · GNB
Pharmacia, Inc.
Microbiology · 359d