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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73105–73128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 03, 2002
NEWCOR
K020440 · DQK
Siemens Medical Systems, Inc.
Cardiovascular · 295d
Cleared Dec 03, 2002
DAUM-LECTRIC MRI DRILLING MACHINE
K021098 · ERL
Mri Devices Daum GmbH
Ear, Nose, Throat · 243d
Cleared Dec 03, 2002
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA...
K022176 · DCK
Orion Diagnostica, Div. Orion Corp.
Immunology · 153d
Cleared Dec 03, 2002
IMTEC SENDAX MDI ORTHO6 AND ORTHO8
K023067 · DZE
Imtec Corp.
Dental · 78d
Cleared Dec 03, 2002
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
K023108 · FMF
Atlantic Products, Inc.
General Hospital · 76d
Cleared Dec 03, 2002
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
K023380 · DQK
General Electric Medical Systems...
Cardiovascular · 56d
Cleared Dec 03, 2002
MODIFICATION TO ENVOY PATIENT MONITOR
K023798 · DSI
Mennen Medical , Ltd.
Cardiovascular · 19d
Cleared Dec 02, 2002
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
K020130 · IPF
Rolor Electronics Corp.
Physical Medicine · 321d
Cleared Dec 02, 2002
EXEL VACULET BLOOD COLLECTION SET
K020533 · FPA
Exelint Intl. Co.
General Hospital · 286d