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
157369–157392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1983
ASAHI HOLLOW FIBER KIDNEYS NR SERIES
K830183 · KOC
Advocacy International, Ltd.
Gastroenterology & Urology · 58d
Cleared Mar 17, 1983
BEDSIDE N.P.T. 9900 - PRINTER 9800
K830221 · LIL
Browne Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 17, 1983
ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES
K830231 · KOC
Advocacy International, Ltd.
Gastroenterology & Urology · 58d
Cleared Mar 17, 1983
FLORET VAGINAL PACKING/TAMPONS
K830260 · GDY
Ritmed, Inc.
General & Plastic Surgery · 51d
Cleared Mar 17, 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306 · DSI
Spacelabs, Inc.
Cardiovascular · 45d
Cleared Mar 17, 1983
SAVETT ALCOHOL PREP
K830330 · LKB
Cederroth, Inc. USA
General Hospital · 44d
Cleared Mar 17, 1983
MARK III OXYGEN WALKER SYS-LOW PRESS
K830337 · BYJ
Union Carbide Corp.
Anesthesiology · 44d
Cleared Mar 17, 1983
CONTAINER W/PRIMING SOLUTION
K830343 · KDP
American Hospital Supply Corp.
General Hospital · 44d
Cleared Mar 17, 1983
RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E
K830357 · DGC
Clinetics Corp.
Chemistry · 42d
Cleared Mar 17, 1983
STERILE CATHERIZATION PROCEDURE TRAYS
K830359 · KOD
Welcon, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 17, 1983
MICRODAPT DENTAL RESTORATIVE
K830380 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 41d
Cleared Mar 17, 1983
COMMAND ULTRA II
K830382 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 41d
Cleared Mar 17, 1983
MICRODAPT DENTAL RESTORATIVE BONDING
K830387 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 41d
Cleared Mar 17, 1983
UNILITH PULSE GENERATOR VVI #7542
K830401 · DXY
Ela Medical, Inc.
Cardiovascular · 38d
Cleared Mar 17, 1983
RAD VALVE
K830404 · BTL
Khi, Inc.
Anesthesiology · 38d
Cleared Mar 17, 1983
CHS
K830437 · JSC
Dms Laboratories
Microbiology · 36d
Cleared Mar 17, 1983
MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM
K830438 · LFJ
Medcomp
Gastroenterology & Urology · 36d
Cleared Mar 17, 1983
PRISMA-FINE
K830442 · EBF
Dentsply Intl.
Dental · 35d
Cleared Mar 17, 1983
PACING LEAD #PMA F 860
K830457 · DTB
Ela Medical, Inc.
Cardiovascular · 36d
Cleared Mar 17, 1983
JOHNSON & JOHNSON OPAQUE COLOR MODIFI
K830491 · EBE
Johnson & Johnson Professionals, Inc.
Dental · 30d
Cleared Mar 17, 1983
ESA ELECTROSURGICAL ARTHROSCOPY GENERA
K830499 · HRX
Concept, Inc.
Orthopedic · 29d
Cleared Mar 17, 1983
ZANLEX, ZAN-TEX & ZANDEX
K830511 · GDY
Winn Hirsch & Assoc.
General & Plastic Surgery · 28d
Cleared Mar 17, 1983
MONO SCREENING TEST
K830531 · KTN
Tago, Inc.
Immunology · 27d
Cleared Mar 17, 1983
INTRAVASCULAR CATHETER SET
K830539 · FOZ
Lab-A-Cath Corp.
General Hospital · 27d