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
72793–72816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · MRC
Ciba Vision Corporation
Ophthalmic · 136d
Cleared Feb 28, 2003
CATHETER CONNECTOR
K023690 · KNY
World Metals, Inc.
Gastroenterology & Urology · 119d
Cleared Feb 28, 2003
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
K023985 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 28, 2003
NYLON SUTURE
K024090 · GAR
Aurolab
General & Plastic Surgery · 79d
Cleared Feb 28, 2003
SILK SUTURES
K024091 · GAP
Aurolab
General & Plastic Surgery · 79d
Cleared Feb 28, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
K030091 · LON
Bd Diagnostic Systems
Microbiology · 49d
Cleared Feb 27, 2003
STARTOX DRUG OF ABUSE SCREENING TEST (4)
K022388 · DJC
Starplex Scientific, Inc.
Toxicology · 219d
Cleared Feb 27, 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K022980 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 171d
Cleared Feb 27, 2003
DISPOSABLE BI-POLAR CABLE
K023966 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 27, 2003
AUTOMED 3200 INFUSION PUMP
K023973 · FRN
Help Technologies
General Hospital · 87d
Cleared Feb 27, 2003
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
K024050 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 80d
Cleared Feb 27, 2003
ALIBI BIOLOGICAL INDICATOR, MODEL WS
K024079 · FRC
Arden Laboratories, Incorporated
General Hospital · 79d
Cleared Feb 27, 2003
TOP GLOVE VINYL EXAMINATION GLOVE
K024216 · LYZ
Top Glove (Zhangjiagang) Co. , Ltd.
General Hospital · 66d
Cleared Feb 27, 2003
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · MED
Advanced Sterilization Products
General Hospital · 56d
Cleared Feb 27, 2003
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50...
K030112 · LYY
Pt. Smartglove Indonesia
General Hospital · 45d
Cleared Feb 27, 2003
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
K030315 · KNS
Ultroid, LLC
Gastroenterology & Urology · 28d
Cleared Feb 27, 2003
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
K030324 · FLL
Radiant Innovation, Inc.
General Hospital · 27d
Cleared Feb 27, 2003
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
K030406 · LZA
Pt. Smartglove Indonesia
General Hospital · 20d
Cleared Feb 26, 2003
V.A.C. ABDOMINAL DRESSING
K022011 · FTL
Kinetic Concepts, Inc.
General & Plastic Surgery · 252d
Cleared Feb 26, 2003
SCLERAL PLUGS, 19 AND 20 GAUGE
K022186 · LXP
Microvision, Inc.
Ophthalmic · 236d
Cleared Feb 26, 2003
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
K022214 · CBF
Mechidyne Systems, Inc.
Anesthesiology · 233d
Cleared Feb 26, 2003
PALABOND
K022251 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 229d
Cleared Feb 26, 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · HWC
Stryker Endoscopy
Orthopedic · 169d
Cleared Feb 26, 2003
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
K023637 · DQD
Tytan Medical Corp.
Cardiovascular · 119d