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
90409–90432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1998
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798 · LIF
Environmental Test Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 20, 1998
BIONX DISTAL RADIUS SCREW
K974876 · MAI
Bionx Implants, Inc.
Orthopedic · 81d
Cleared Mar 20, 1998
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881 · MCB
Biosite Incorporated
Microbiology · 80d
Cleared Mar 20, 1998
MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
K980062 · FMI
Davis & Geck, Inc.
General Hospital · 72d
Cleared Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119 · DQX
Guidant Corp.
Cardiovascular · 66d
Cleared Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666 · CIT
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 20, 1998
RAPID DRUG SCREEN' 8 PANEL
K980872 · DIO
American Bio Medica Corp.
Toxicology · 14d
Cleared Mar 19, 1998
TUMORLOCALIZER MRI
K962615 · MIG
Ferguson Medical
Toxicology · 624d
Cleared Mar 19, 1998
PUNCTURENEEDLE
K963794 · KNW
Ferguson Medical
Gastroenterology & Urology · 545d
Cleared Mar 19, 1998
TYROSINE 50-HOUR REAGENT KIT
K970093 · CDR
Astoria-Pacific, Inc.
Chemistry · 433d
Cleared Mar 19, 1998
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
K973532 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 182d
Cleared Mar 19, 1998
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K973839 · BZT
Catheter Research, Inc.
Anesthesiology · 162d
Cleared Mar 19, 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · LBH
Pulpdent Corp.
Dental · 129d
Cleared Mar 19, 1998
ORATEC SPINECATH INTRADISCAL CATHETER
K974464 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 113d
Cleared Mar 19, 1998
ELMED ESU 120 M/M DIGITAL
K974793 · GEI
Elmed, Inc.
General & Plastic Surgery · 87d
Cleared Mar 19, 1998
JENASCAN
K980001 · GEX
Jenoptik Laser, Optik, Systeme GmbH
General & Plastic Surgery · 76d
Cleared Mar 19, 1998
IL TEST HEPARIN
K980242 · KFF
Instrumentation Laboratory CO
Hematology · 55d
Cleared Mar 19, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
K980313 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 51d
Cleared Mar 19, 1998
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
K980523 · CHL
Diametrics Medical, Inc.
Chemistry · 37d
Cleared Mar 19, 1998
DERMIUM
K980561 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 34d
Cleared Mar 19, 1998
LD2000 SERIES
K980565 · LMA
General Scanning, Inc.
Radiology · 34d
Cleared Mar 19, 1998
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K980698 · DZE
Astra Tech, Inc.
Dental · 24d
Cleared Mar 19, 1998
A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
K980824 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Mar 18, 1998
INCL II ENDOSCOPE
K963642 · GWG
Sofamor Danek USA,Inc.
Neurology · 552d