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
78817–78840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2001
I-STAT SYSTEM
K011478 · KHP
I-Stat Corp.
Chemistry · 49d
Cleared Jul 02, 2001
10% PVP
K011481 · MQL
Conception Technologies
Obstetrics & Gynecology · 49d
Cleared Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE...
K011505 · CEW
Diagnostic Products Corp.
Chemistry · 47d
Cleared Jul 02, 2001
HYALURONIDASE IN HTF MEDIUM
K011573 · MQL
Conception Technologies
Obstetrics & Gynecology · 42d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · HWC
Plus Orthopedics
Orthopedic · 28d
Cleared Jul 02, 2001
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
K011740 · MML
Meddev Corp.
Ophthalmic · 27d
Cleared Jul 02, 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824 · DSI
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920 · KXT
Syva Co., Dade Behring, Inc.
Toxicology · 12d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · LEG
Syva Co.
Toxicology · 11d
Cleared Jun 29, 2001
HOME HEALTH MONITORING SYSTEM
K010029 · DXN
Avid Care Corp.
Cardiovascular · 177d
Cleared Jun 29, 2001
ZURICH DISTRACTION SYSTEM
K010139 · MQN
KLS-Martin L.P.
Dental · 163d
Cleared Jun 29, 2001
LIPOMATIC
K010311 · QPB
Euromi S.A
General & Plastic Surgery · 148d
Cleared Jun 29, 2001
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
K010692 · FMF
Spintech, Inc.
General Hospital · 113d
Cleared Jun 29, 2001
TRAM 2001 MODULE
K011000 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · GAM
Aesculap, Inc.
General & Plastic Surgery · 56d
Cleared Jun 29, 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394 · EIH
Espe Dental AG
Dental · 53d
Cleared Jun 29, 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · EHD
Planmeca Oy
Radiology · 35d
Cleared Jun 29, 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · KTT
Ebi, L.P.
Orthopedic · 25d
Cleared Jun 28, 2001
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
K002409 · LGZ
Automatic Medical Technologies, Inc.
General Hospital · 325d
Cleared Jun 28, 2001
HOMMED OBSERVER, MODEL I
K003180 · DXN
Hommed, LLC
Cardiovascular · 260d
Cleared Jun 28, 2001
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K003663 · BSZ
Spacelabs Medical, Inc.
Anesthesiology · 212d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · GWM
Aesculap, Inc.
Neurology · 204d
Cleared Jun 28, 2001
AVIVA SYSTEM, MODEL SL 2020
K003999 · MWI
American Telecare, Inc.
Cardiovascular · 184d
Cleared Jun 28, 2001
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
K010422 · GWM
Innerspace, Inc.
Neurology · 136d