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
130633–130656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1989
CTI II STRAIGHT STEM
K891539 · LWJ
Orthopedic Systems, Inc.
Orthopedic · 83d
Cleared Jun 08, 1989
S 22 INSTRUMENT STAND
K891584 · HRM
Carl Zeiss, Inc.
General & Plastic Surgery · 80d
Cleared Jun 08, 1989
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
K891753 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 08, 1989
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K
K891755 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 08, 1989
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER
K891997 · HFM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 72d
Cleared Jun 08, 1989
RUBELLA-CUBE(TM)
K892051 · LFX
Difco Laboratories, Inc.
Microbiology · 71d
Cleared Jun 08, 1989
SURGICAL LATEX STERILE GLOVES
K892056 · KGO
Modern Rubber Industrial Co., Ltd.
General Hospital · 76d
Cleared Jun 08, 1989
SITE PHACO PLUS INFUSION SLEEVE
K892852 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 51d
Cleared Jun 08, 1989
QUINTON SINGLE LUMEN CATHETER
K893188 · MPB
Quinton, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 08, 1989
DELCLAMP
K893231 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 08, 1989
T SERIES VESSEL TIPS
K893438 · FKW
Akcess Medical Products, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 08, 1989
NU-TRAP SUCTION CATHETER W/MUCUS TRAP
K893462 · BSY
Atheus Corp.
Anesthesiology · 36d
Cleared Jun 08, 1989
DA-16 AND DA-24 SHUNT ADAPTERS
K893478 · FKN
Akcess Medical Products, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 08, 1989
COMBOLASER MODEL 5050
K893529 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 31d
Cleared Jun 07, 1989
MONAGHAN RVM, MODEL 761
K884942 · BZK
Monaghan Medical Corp.
Anesthesiology · 194d
Cleared Jun 07, 1989
MIX CONTAINER W/ATTACHED TRANSFER SET
K885173 · KPE
Medical Support Systems
General Hospital · 176d
Cleared Jun 07, 1989
DENTCLEAN CONCENTRATED DENTURE CLEANSER
K890043 · EFT
K-P Co.
Dental · 153d
Cleared Jun 07, 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 07, 1989
MICROSEPT 60/20
K890844 · CAK
Arbor Technologies, Inc.
General Hospital · 106d
Cleared Jun 07, 1989
ATRAUMAX(TM) SURGICAL CLAMPS
K891296 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 86d
Cleared Jun 07, 1989
SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE
K891452 · IYO
Diasonics, Inc.
Radiology · 84d
Cleared Jun 07, 1989
EXETER II TOTAL HIP SYSTEM
K891454 · JDI
Howmedica Corp.
Orthopedic · 84d
Cleared Jun 07, 1989
TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO
K891473 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 83d
Cleared Jun 07, 1989
TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION
K891474 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 83d