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
72289–72312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 26, 2003
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
K023917 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 93d
Cleared Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023987 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023989 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 79d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Feb 26, 2003
B.07 STAIRWAY CHAIRLIFT
K024345 · ILK
Services Industriels Savaria, Inc.
Physical Medicine · 61d
Cleared Feb 26, 2003
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054 · HJK
Fci Ophthalmics, Inc.
Ophthalmic · 51d
Cleared Feb 26, 2003
MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
K030141 · DTQ
Cardiovention, Inc.
Cardiovascular · 42d
Cleared Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · MQV
Biomet, Inc.
Orthopedic · 40d