Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
158209–158232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1983
RIGHT TIME RHYTHM CLOCK
K823463 · LHD
P.K. Morgan Instruments, Inc.
Obstetrics & Gynecology · 118d
Cleared Mar 17, 1983
AMP 80/2 OUTFLOW MONITOR MODIFICATION
K823827 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 17, 1983
THERACARD 400
K823828 · LDD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 87d
Cleared Mar 17, 1983
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 85d
Cleared Mar 17, 1983
T-TUBE VENT TUBE
K823909 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 17, 1983
IMPROVED ARTHROSCOPE
K830120 · HRX
Markoptic
Orthopedic · 65d
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