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
75481–75504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621 · HRY
Biomet, Inc.
Orthopedic · 20d
Cleared Jun 05, 2002
PHYSICIAN'S DESKTOP REVIEW
K021669 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Jun 04, 2002
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
K010132 · DZE
SOADCO, S.L.
Dental · 504d
Cleared Jun 04, 2002
PHYSIOLOG, SERIES 95000
K013032 · DQK
Camtronics, Ltd.
Cardiovascular · 267d
Cleared Jun 04, 2002
HYPERION VISIQUANT ANA TEST KIT
K013213 · DHN
Hyperion, Inc.
Immunology · 251d
Cleared Jun 04, 2002
SILICONE TRACHEAL T-TUBES
K013321 · BTR
Technical Products, Inc.
Anesthesiology · 242d
Cleared Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · JGS
Phoenix Diagnostics, Inc.
Chemistry · 120d
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · DJG
Lin-Zhi International, Inc.
Toxicology · 120d
Cleared Jun 04, 2002
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · MVN
Ocular Sciences
Ophthalmic · 119d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041...
K020395 · DKZ
Lin-Zhi International, Inc.
Toxicology · 118d
Cleared Jun 04, 2002
CARESIDE ALT
K020487 · CKA
Careside, Inc.
Chemistry · 111d
Cleared Jun 04, 2002
NLITE SYSTEM,MODEL A00-1051
K020729 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 04, 2002
UNICONDYLAR KNEE
K020741 · HRY
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jun 04, 2002
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL...
K020855 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 81d
Cleared Jun 04, 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 41d
Cleared Jun 04, 2002
PARACON II/FECAL CONCENTRATOR II
K021420 · LKS
Para Scientific Co.
Microbiology · 32d
Cleared Jun 04, 2002
ANIMUS EZSERTER INFUSION SET INSERTER
K021700 · KZH
Animas Corp.
General Hospital · 12d
Cleared Jun 03, 2002
REPROCESSED ARTHROSCOPIC SHAPERS
K012667 · HRX
Surgical Instruments Service and...
Orthopedic · 294d
Cleared Jun 03, 2002
SYSTEM 100
K013733 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 206d
Cleared Jun 03, 2002
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE...
K014040 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 178d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · DKZ
Biosite Incorporated
Toxicology · 159d
Cleared Jun 03, 2002
WALLACH LOOP ELECTRODE
K020711 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 90d
Cleared Jun 03, 2002
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
K020718 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
Cleared Jun 03, 2002
TRAATEK COTTONOID PATTIES
K020736 · HBA
Traatek, Inc.
Neurology · 89d