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

Filters: Cleared only ×
175,820 results
135481–135504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1988
NEPHROSS I.Q. MODERATO
K882215 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 33d
Cleared Jun 28, 1988
HI FLOW 50
K882328 · BYJ
Minnesota Valley Engineering, Inc.
Anesthesiology · 22d
Cleared Jun 28, 1988
BIO*NEPHROSS I.Q. ANDANTE
K882339 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 22d
Cleared Jun 28, 1988
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351 · JTZ
Lakewood Biochemical Co., Inc.
Microbiology · 21d
Cleared Jun 28, 1988
HOOD TRACHEAL STOMA BUTTON
K882430 · BTO
Hood Laboratories
Anesthesiology · 14d
Cleared Jun 28, 1988
JAYCO HYDROGEN MONITOR
K882499 · NRH
Enteron, Inc.
Chemistry · 11d
Cleared Jun 27, 1988
NEW JELLIACOAT
K880189 · HIS
K&G Import/Export Co.
Obstetrics & Gynecology · 159d
Cleared Jun 27, 1988
SURGICAL GARMENTS
K880484 · FYC
Greene International Corp.
General Hospital · 144d
Cleared Jun 27, 1988
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
K881358 · HOX
Neuroscientific Corp.
Ophthalmic · 88d
Cleared Jun 27, 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · JPA
Instrumentation Laboratory CO
Hematology · 88d
Cleared Jun 27, 1988
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · CAC
Shiley, Inc.
Anesthesiology · 69d
Cleared Jun 27, 1988
KTP/532(TM) SURGICAL LASER
K881788 · GEX
Laserscope
General & Plastic Surgery · 62d
Cleared Jun 27, 1988
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · NAD
3M Company
General & Plastic Surgery · 46d
Cleared Jun 27, 1988
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT
K882253 · KNN
Stoute'S "Assist-Seat" Corp.
Physical Medicine · 27d
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