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
90193–90216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1998
QUIKPAC II ONE STEP BENZODIAZEPINE TEST
K973326 · JXM
Drial Consultants, Inc.
Toxicology · 173d
Cleared Feb 24, 1998
HERMES OPERATING ROOM CONTROL CENTER
K973700 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 151d
Cleared Feb 24, 1998
TESTOTERONE ELISA
K973900 · CDZ
Kmi Diagnostics, Inc.
Chemistry · 133d
Cleared Feb 24, 1998
STERI-TAMP
K974180 · KPE
Pharmacy, Inc.
General Hospital · 110d
Cleared Feb 24, 1998
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
K974469 · HQC
Mentor Corp.
Ophthalmic · 90d
Cleared Feb 24, 1998
PEGASYS INTOUCH
K974474 · LLZ
Adac Laboratories
Radiology · 90d
Cleared Feb 24, 1998
SILIMED CALF IMPLANT
K974480 · MIB
Silimed, LLC
General & Plastic Surgery · 90d
Cleared Feb 24, 1998
SILIMED GLUTEAL IMPLANT
K974482 · MIB
Silimed, LLC
General & Plastic Surgery · 90d
Cleared Feb 24, 1998
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION
K974485 · LPN
Szabocsik and Assoc.
Ophthalmic · 90d
Cleared Feb 24, 1998
SYNTHES RESORBABLE FIXATION SYSTEM
K974554 · JEY
Synthes (Usa)
Dental · 82d
Cleared Feb 24, 1998
MDA SIMPLASTIN HTF
K974566 · GJS
Organon Teknika Corp.
Hematology · 81d
Cleared Feb 24, 1998
SILICONE BLOCKS
K974654 · MIB
Specialty Surgical Products, Inc.
General & Plastic Surgery · 71d
Cleared Feb 24, 1998
JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED...
K974727 · EBI
J.B.C and Co.
Dental · 68d
Cleared Feb 24, 1998
LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
K974782 · LYY
Mexpo Intl., Inc.
General Hospital · 64d
Cleared Feb 24, 1998
AVL OPTI CRITICAL CARE ANALYZER
K974784 · CEM
Avl Scientific Corp.
Chemistry · 64d
Cleared Feb 24, 1998
SYNERMED CREATININE REAGENT KIT
K974909 · CGX
Synermed Intl., Inc.
Chemistry · 55d
Cleared Feb 24, 1998
PALFIQUE ESTELITE PASTE
K980051 · EBF
Tokuyama America, Inc.
Dental · 49d
Cleared Feb 24, 1998
GLENROE CHAIN
K980053 · ECI
Glenroe Technologies
Dental · 49d
Cleared Feb 24, 1998
PHACO COMMANDER
K980085 · HQC
Scieran Technologies, Inc.
Ophthalmic · 46d
Cleared Feb 24, 1998
CLEARFIL DC CEMENT
K980232 · EMA
Kuraray Company, Ltd.
Dental · 33d
Cleared Feb 24, 1998
MTA MATERIAL
K980332 · KIF
Dentsply Intl.
Dental · 27d
Cleared Feb 24, 1998
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY...
K980466 · JOH
Sims Portex, Inc.
Anesthesiology · 18d
Cleared Feb 24, 1998
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · MMK
Sage Products, Inc.
General Hospital · 15d
Cleared Feb 23, 1998
MEDCOMP BIO-FLEX CS CATHETER (CS100)
K971925 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 276d