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
72385–72408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2003
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
K030340 · JQC
Cytomedix
Hematology · 70d
Cleared Apr 11, 2003
HL888HA
K030498 · DXN
Health & Life Co., Ltd.
Cardiovascular · 51d
Cleared Apr 11, 2003
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K030555 · JQC
Biomet, Inc.
Hematology · 49d
Cleared Apr 11, 2003
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH,...
K030696 · DWF
Medtronic Perfusion Systems
Cardiovascular · 36d
Cleared Apr 11, 2003
RDI EXTENDED RANGE CRP CALIBRATOR SET
K030772 · JIT
Reference Diagnostics, Inc.
Immunology · 31d
Cleared Apr 11, 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 11d
Cleared Apr 10, 2003
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · HET
CooperSurgical, Inc.
Obstetrics & Gynecology · 357d
Cleared Apr 10, 2003
CARE STIM
K022417 · GZJ
Care Rehab and Orthopaedic
Neurology · 260d
Cleared Apr 10, 2003
HYSTEREOSCOPY PUMP HM4
K022449 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 258d
Cleared Apr 10, 2003
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
K023096 · HSD
Std Mfg., Inc.
Orthopedic · 204d
Cleared Apr 10, 2003
BIOFLEX PROFESSIONAL THERAPY SYSTEM
K023621 · ILY
Meditech International, Inc.
Physical Medicine · 163d
Cleared Apr 10, 2003
VITALCARE URETHRAL CATHETER RED RUBBER
K023872 · EZD
Vitalcare, Inc.
Gastroenterology & Urology · 141d
Cleared Apr 10, 2003
EVERSTICK PERIO
K030072 · EBI
Stick Tech , Ltd.
Dental · 92d
Cleared Apr 10, 2003
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
K030151 · LZO
Hayes Medical, Inc.
Orthopedic · 85d
Cleared Apr 10, 2003
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
K030437 · IRP
Salton, Inc.
Physical Medicine · 59d
Cleared Apr 10, 2003
I-125 RAPID STRAND, MODEL 7000
K030594 · KXK
Amersham Health
Radiology · 44d
Cleared Apr 10, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
K030804 · JIX
Bayer Healthcare, LLC
Chemistry · 28d
Cleared Apr 10, 2003
DEPUY ACROMED VBR SYSTEM
K030833 · MQP
Depuyacromed
Orthopedic · 24d
Cleared Apr 10, 2003
AVANTA CARPAL FUSION PLATING SYSTEM
K030881 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 21d
Cleared Apr 10, 2003
AAP ACROPLATE
K030909 · HRS
Aap Implantate AG
Orthopedic · 17d
Cleared Apr 10, 2003
GE 3.0T GENERAL PURPOSE FLEX COIL
K030953 · MOS
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Apr 09, 2003
MID STREAM PREGNANCY TEST
K023037 · LCX
Advanced Diagnostics, Inc.
Chemistry · 209d
Cleared Apr 09, 2003
LOOP MICROWAVE ABLATION PROBE
K023311 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 188d
Cleared Apr 09, 2003
THERMO BUDDY, MODELS TB-100, TB-110, TB-120
K023412 · FLL
Hubdic Co., Ltd.
General Hospital · 180d