Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72985–73008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2003
PASCO MIC AND MIC/ID PANELS
K030620 · LTT
Pasco Laboratories, Inc.
Microbiology · 46d
Cleared Apr 14, 2003
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K030650 · CEN
Uridynamics, Inc.
Chemistry · 45d
Cleared Apr 14, 2003
PROTEC-TOP, STERIDENT, BENTO
K031022 · FRG
Ronpak, Inc.
General Hospital · 14d
Cleared Apr 11, 2003
GOLDWAY PATIENT MONITOR, MODEL # UT4000F
K021154 · MWI
Goldway Us, Inc.
Cardiovascular · 366d
Cleared Apr 11, 2003
SK MED M201 MIXER
K022864 · BZR
Sk Med
Anesthesiology · 226d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · LDJ
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Apr 11, 2003
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE...
K030270 · LJS
Medcomp
General Hospital · 74d
Cleared Apr 11, 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN...
K030320 · JIS
Wako Chemicals USA, Inc.
Chemistry · 71d
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