FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85537–85560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1999
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
K991866 · CIG
A.P. Total Care, Inc.
Chemistry · 62d
Cleared Aug 02, 1999
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
K991867 · CEO
A.P. Total Care, Inc.
Chemistry · 62d
Cleared Aug 02, 1999
MEDTRONIC AVE BRIDGE STENT
K992318 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 02, 1999
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438 · LTZ
Indus Medicare , Ltd.
Obstetrics & Gynecology · 11d
Cleared Jul 30, 1999
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
K982859 · HRY
Plus Orthopedics
Orthopedic · 351d
Cleared Jul 30, 1999
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB,...
K983802 · MJN
Lucas Medical, Inc.
Cardiovascular · 275d
Cleared Jul 30, 1999
AGC V2 REVISION KNEE SYSTEM
K984054 · JWH
Biomet, Inc.
Orthopedic · 259d
Cleared Jul 30, 1999
AVE GL-1 GUIDING CATHETER
K984482 · DQY
Arterial Vascular Engineering...
Cardiovascular · 226d
Cleared Jul 30, 1999
HT, MODEL HT PB
K990142 · DTB
Sulzer Oscor, Inc.
Cardiovascular · 192d
Cleared Jul 30, 1999
RABEA DEVICE, MODEL PXXXXXX
K990345 · JDK
Signus Medizintechnik GmbH
Orthopedic · 176d
Cleared Jul 30, 1999
DENTEC LD 15 DIODE LASER
K990680 · GEX
Dentek Lasersystems Produktions...
General & Plastic Surgery · 150d
Cleared Jul 30, 1999
BIORC ANCHOR
K990770 · HWC
Linvatec Corp.
Orthopedic · 143d
Cleared Jul 30, 1999
POLARIS DIODE LASER SYSTEM AND ACCESSORIES
K990914 · GEX
Xintec Corporation
General & Plastic Surgery · 134d
Cleared Jul 30, 1999
ACIER SUTURES
K991073 · GAQ
Cardio Thoracic Systems
General & Plastic Surgery · 121d
Cleared Jul 30, 1999
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW...
K991520 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared Jul 30, 1999
TLC PEDIATRIC FRAME, MODEL TLC-SYS
K991523 · IYE
Radionics, Inc.
Radiology · 88d
Cleared Jul 30, 1999
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991535 · KPS
Hitachi Medical Corp. of America
Radiology · 88d
Cleared Jul 30, 1999
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
K991546 · IYE
Aktina Medical Physics Corp.
Radiology · 88d
Cleared Jul 30, 1999
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS)
K991581 · JWH
Zimmer, Inc.
Orthopedic · 84d
Cleared Jul 30, 1999
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE...
K991615 · LZA
Maxxim Medical
General Hospital · 81d
Cleared Jul 30, 1999
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K991625 · HBB
Komet Medical
Neurology · 80d
Cleared Jul 30, 1999
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
K991708 · LZO
Biomet, Inc.
Orthopedic · 72d
Cleared Jul 30, 1999
SIDESTREAM NEBULIZER
K991725 · CAF
Inspired Medical Products , Ltd.
Anesthesiology · 71d
Cleared Jul 30, 1999
LACTOSORB HAND SYSTEM
K991763 · HRS
Biomet, Inc.
Orthopedic · 67d