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
73609–73632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · DIO
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Dec 06, 2002
VITAL STIM
K023347 · IPF
Chattanooga Group
Physical Medicine · 60d
Cleared Dec 06, 2002
PORTA GEO TI
K023389 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
AGC SPECIAL ALLOY
K023392 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH...
K023577 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 44d
Cleared Dec 06, 2002
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K023661 · JJY
Cliniqa Corporation
Chemistry · 36d
Cleared Dec 06, 2002
O.B. TAMPONS
K023789 · HEB
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 23d
Cleared Dec 06, 2002
MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
K023846 · GEI
Rita Medical Systems
General & Plastic Surgery · 17d
Cleared Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · LTK
Tosoh Medics, Inc.
Immunology · 14d
Cleared Dec 05, 2002
ASCENDENT ACETABULAR SYSTEM
K022985 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Dec 05, 2002
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K023007 · HRS
Hand Innovations, Inc.
Orthopedic · 87d
Cleared Dec 05, 2002
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K023716 · FRC
Spsmedical Supply Corp.
General Hospital · 30d
Cleared Dec 05, 2002
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
K023757 · GEH
Endocare, Inc.
General & Plastic Surgery · 27d
Cleared Dec 04, 2002
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · KRO
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Dec 04, 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND...
K022048 · KWP
Interpore Cross Intl.
Orthopedic · 163d
Cleared Dec 04, 2002
TRANSONIC SYRINGE WARMER, MODEL SYR-1000
K022963 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 04, 2002
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
K023016 · DRN
Nicore Equipment & Leasing, Inc.
Cardiovascular · 85d
Cleared Dec 04, 2002
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
K023242 · KXK
Implant Sciences Corp.
Radiology · 65d
Cleared Dec 04, 2002
PEDIATRIC ARTERIAL CANNULA
K023251 · DWF
Polystan A/S
Cardiovascular · 65d
Cleared Dec 04, 2002
GIZMO
K023574 · IOR
Freedom Designs, Inc.
Physical Medicine · 41d
Cleared Dec 04, 2002
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
K023700 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2002
QUICKSET MIMIX BONE VOID FILLER
K023718 · GXP
Walter Lorenz Surgical, Inc.
Neurology · 29d
Cleared Dec 04, 2002
MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR...
K023810 · JEY
Bioplate, Inc.
Dental · 19d
Cleared Dec 04, 2002
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE...
K023871 · MHX
Philips Medical Systems
Cardiovascular · 14d