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
114937–114960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1992
BISCO D/C RESINOMER
K924151 · EBF
Bisco, Inc.
Dental · 132d
Cleared Dec 28, 1992
VACUPLUS TUBES WITH BRICK RED STOPPERS
K924365 · JKA
Starplex Scientific, Inc.
Chemistry · 122d
Cleared Dec 28, 1992
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
K924853 · JJX
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 28, 1992
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET
K924862 · JJX
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 28, 1992
CONCEIVE ONE-STEP PREGNANCY TEST
K925096 · LCX
Quidel Corp.
Chemistry · 81d
Cleared Dec 28, 1992
PHILIPS MEDIO CP FAMILY
K925105 · IZO
Philips Medical Systems, Inc.
Radiology · 81d
Cleared Dec 28, 1992
BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE
K925132 · JLW
Becton Dickinson Advanced Diagnostics
Chemistry · 76d
Cleared Dec 28, 1992
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
K925208 · LGC
Ortho Diagnostic Systems, Inc.
Microbiology · 91d
Cleared Dec 28, 1992
LIXI IMAGING SCOPE. MODIFICATION
K925251 · JAA
Lixi, Inc.
Radiology · 73d
Cleared Dec 28, 1992
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K925257 · KHQ
Ciba Corning Diagnostics Corp.
Chemistry · 70d
Cleared Dec 28, 1992
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · CDP
Medix Biotech, Inc.
Chemistry · 61d
Cleared Dec 28, 1992
DETECTABUSE(TM)
K925586 · DIF
Biochemical Diagnostic, Inc.
Toxicology · 54d
Cleared Dec 28, 1992
CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
K925668 · CGX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 48d
Cleared Dec 28, 1992
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
K925705 · IWY
Denar Corp.
Radiology · 46d
Cleared Dec 28, 1992
REP E-Z CK-30 ISOENZYME KIT
K925801 · CGS
Helena Laboratories
Chemistry · 42d
Cleared Dec 28, 1992
PHILIPS SUPER CP FAMILY
K925844 · IZO
Philips Medical Systems, Inc.
Radiology · 40d
Cleared Dec 28, 1992
CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3
K926015 · JJX
Cala Diagnostics
Chemistry · 28d
Cleared Dec 24, 1992
PERFECTA TOTAL HIP SYSTEM, HA COATED
K915190 · MEH
Orthomet, Inc.
Orthopedic · 398d
Cleared Dec 24, 1992
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
K920778 · DXN
Omron Healthcare, Inc.
Cardiovascular · 308d
Cleared Dec 24, 1992
ENDOSCOPE
K921040 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 295d
Cleared Dec 24, 1992
HAEMOTROL MODEL #HT-SB/6 BURETTE SET
K921594 · FPA
Haemotronic, Inc.
General Hospital · 265d
Cleared Dec 24, 1992
Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2
K921595 · BRZ
Haemotronic, Inc.
General Hospital · 265d
Cleared Dec 24, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K921653 · LNH
General Electric Co.
Radiology · 261d
Cleared Dec 24, 1992
LAPAROSCOPIC CURVED TRIANGLE RETRACTOR
K922435 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 216d