FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133729–133752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1988
ALPHACALF SERUM
K884654 · KIT
Hyclone Laboratories, Inc.
Pathology · 23d
Cleared Nov 30, 1988
ZIMMER BEADED THREADED ACETABULAR CUP
K884658 · KWY
Zimmer, Inc.
Orthopedic · 23d
Cleared Nov 30, 1988
MQL 20 ND:YAG OPHTHALMIC LASER
K884694 · LQJ
California Laboratories, Inc.
Ophthalmic · 21d
Cleared Nov 30, 1988
SHOWER CHAIR
K884760 · INM
Linido, Inc.
Physical Medicine · 16d
Cleared Nov 30, 1988
RANEY CLIP
K884783 · FZQ
Alto Development Corp.
General & Plastic Surgery · 15d
Cleared Nov 29, 1988
ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY
K881140 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 257d
Cleared Nov 29, 1988
TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER
K881303 · DPT
Triton Technology, Inc.
Cardiovascular · 246d
Cleared Nov 29, 1988
GLASS IONOMER BASE
K882751 · EJK
Dentsply Intl.
Dental · 147d
Cleared Nov 29, 1988
MODEL 500V VASCULAR SPECTRUM ANALYZER
K882755 · IYN
Multigon Industries, Inc.
Radiology · 147d
Cleared Nov 29, 1988
TECHNICON ASSIST POTASSIUM
K883585 · CEJ
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
TECHNICON RA-100 SYSTEM POTASSIUM
K883586 · CEJ
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
ZINC OXIDE EUGENOL TEMPORARY CEMENT
K883698 · EMA
E&D Dental Manufacturing Co.
Dental · 91d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730 · JXM
Abbott Laboratories
Toxicology · 90d
Cleared Nov 29, 1988
HOME CLINIC PREGNANCY TEST
K883826 · LCX
Vanguard Biomedical Corp.
Chemistry · 81d
Cleared Nov 29, 1988
CERVICAL BIOPSY INSTRUMENT
K883867 · HEB
Mend Technologies, Inc.
Obstetrics & Gynecology · 77d
Cleared Nov 29, 1988
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · JOP
General Electric Co.
Cardiovascular · 76d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
K883890 · DIH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Nov 29, 1988
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
K883962 · CEO
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138 · CEP
Abbott Laboratories
Chemistry · 60d
Cleared Nov 29, 1988
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
K884168 · JIS
The DU Pont Co.
Chemistry · 56d
Cleared Nov 29, 1988
LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
K884362 · HQJ
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 40d
Cleared Nov 29, 1988
LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
K884363 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 40d
Cleared Nov 29, 1988
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
K884364 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 40d