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
134905–134928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1988
ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
K875042 · LKW
Surgilase, Inc.
Neurology · 200d
Cleared Jun 24, 1988
MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN
K875219 · LDJ
Keystone Diagnostics, Inc.
Toxicology · 185d
Cleared Jun 24, 1988
FERTILITY FORECASTER COMPUTER PROGRAM
K880618 · LHD
Fertile Time, Ltd.
Obstetrics & Gynecology · 129d
Cleared Jun 24, 1988
MODIFIED DIGITAL CLINICAL THERMOMETER
K880759 · FLL
Epson America, Inc.
General Hospital · 120d
Cleared Jun 24, 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963 · FMF
Buckman Co., Inc.
General Hospital · 108d
Cleared Jun 24, 1988
ICU SARACAP
K881093 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 101d
Cleared Jun 24, 1988
MICROMEDIC MORPHINE RIA KIT
K881102 · DOE
Icn Micromedic Systems
Toxicology · 101d
Cleared Jun 24, 1988
HUMID-VENT FILTER
K881657 · BYD
Gibeck Respiration
Anesthesiology · 70d
Cleared Jun 24, 1988
NASAL CPAP SYSTEM
K881833 · BYE
Healthdyne, Inc.
Anesthesiology · 56d
Cleared Jun 24, 1988
GDS ENZYMATIC SALICYLATE REAGENT
K882038 · DKJ
Gds Technology, LLC
Chemistry · 39d
Cleared Jun 24, 1988
TOTAL PROTEIN/ALBUMIN STANDARD
K882116 · JIX
Verichem Laboratories, Inc.
Chemistry · 36d
Cleared Jun 24, 1988
SARACAP AG
K882172 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 31d
Cleared Jun 24, 1988
DELFIA ESTRADIOL KIT
K882173 · CHP
Pharmacia, Inc.
Chemistry · 31d
Cleared Jun 24, 1988
MODEL 172-P AND 172-N ROTARY SPRAY ARM
K882465 · FLE
Boling Precision Components Co.
General Hospital · 9d
Cleared Jun 23, 1988
EUB-450 DIAGNOSTIC ULTRASOUND DEVICE
K874211 · IYO
Hitachi Medical Corp. of America
Radiology · 251d
Cleared Jun 23, 1988
TITANIUM BACKSTOP WITH SUCTION
K874611 · HET
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
TITANIUM RODS
K874612 · HET
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
SUCTION AND LAVAGE PROBE
K874614 · HET
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
LASER CANNISTER FILTER
K874615 · HHR
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
TDP, LARK BRAND AND MIT LAMP
K875052 · ILY
I.E.C. Co.
Physical Medicine · 197d
Cleared Jun 23, 1988
KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN
K880382 · FYA
Kimberly-Clark Corp.
General Hospital · 147d
Cleared Jun 23, 1988
KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON
K880383 · FYA
Kimberly-Clark Corp.
General Hospital · 147d
Cleared Jun 23, 1988
KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT
K880384 · BWP
Kimberly-Clark Corp.
General & Plastic Surgery · 147d
Cleared Jun 23, 1988
KIMBERLY-CLARK PROTECTIVE SLEEVE
K880386 · FYA
Kimberly-Clark Corp.
General Hospital · 147d