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
84193–84216 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1999
AROMATIC AND FLAVORED TONGUE DEPRESSOR
K992995 · FMA
Aga Plastic Ind. Com. Ltda.
General Hospital · 93d
Cleared Dec 09, 1999
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1,...
K993054 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Dec 09, 1999
RUSCH BRILLANT SILICONE FOLEY
K993063 · EZL
Rusch Intl.
Gastroenterology & Urology · 87d
Cleared Dec 09, 1999
FRIALIT-2 SELECT COMPONENTS
K993095 · DZE
Friadent GmbH
Dental · 84d
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Dec 09, 1999
XOMED ENT RF SYSTEM
K993112 · GEI
Xomed, Inc.
General & Plastic Surgery · 83d
Cleared Dec 09, 1999
AUROFLUID M, ALLOY NO. 5315
K993475 · EJS
Metalor Dental USA Corp.
Dental · 56d
Cleared Dec 09, 1999
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
K993631 · JJY
Seracare Technology
Immunology · 43d
Cleared Dec 09, 1999
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
K993821 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 27d
Cleared Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Dec 08, 1999
NEXFLEX TOTAL KNEE SYSTEM
K991882 · JWH
Nexmed, Inc.
Orthopedic · 189d
Cleared Dec 08, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT...
K992595 · MHX
Hewlett-Packard GmbH
Cardiovascular · 127d
Cleared Dec 08, 1999
V-DELTA SPECIAL, ALLOY NO. 5154
K993505 · EJS
Metalor Dental USA Corp.
Dental · 54d
Cleared Dec 08, 1999
PAGALINOR 4 , ALLOY NO. 5440
K993506 · EJS
Metalor Dental USA Corp.
Dental · 54d
Cleared Dec 08, 1999
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K993766 · MUJ
Helax AB
Radiology · 30d
Cleared Dec 07, 1999
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
K984168 · FCF
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 382d
Cleared Dec 07, 1999
PHILIPS EASYVISION WORKSTATION
K990329 · LNH
Philips Medical Systems North...
Radiology · 308d
Cleared Dec 07, 1999
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
K990643 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 284d
Cleared Dec 07, 1999
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · HAW
Stryker Corp.
Neurology · 202d
Cleared Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · GKP
Dade Behring, Inc.
Hematology · 67d
Cleared Dec 07, 1999
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
K993774 · DXT
Acist Medical Systems
Cardiovascular · 29d
Cleared Dec 07, 1999
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
K993945 · LCM
Bionike Laboratories, Inc.
Toxicology · 18d
Cleared Dec 06, 1999
OPTISTAR MR INJECTOR SYSTEM
K984088 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 385d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110 · DRX
Maersk Medical A/S
Cardiovascular · 327d