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
75697–75720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2002
I-STAT PROTHROMBIN TIME TEST
K020355 · GJS
I-Stat Corporation
Hematology · 99d
Cleared May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
K020489 · JPD
Tosoh Medics, Inc.
Hematology · 90d
Cleared May 14, 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · GLK
Aalto Scientific, Ltd.
Hematology · 78d
Cleared May 14, 2002
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
K020664 · MMK
Sterilogic Waste Systems, Inc.
General Hospital · 74d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 70d
Cleared May 14, 2002
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · JIY
Diagnostic Chemicals , Ltd.
Chemistry · 62d
Cleared May 14, 2002
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
K020823 · DFZ
Sanquin Blood Supply Foundation
Immunology · 61d
Cleared May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021058 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021059 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SL-PLUS LATERALIZED STEM
K021178 · JDI
Plus Orthopedics
Orthopedic · 29d
Cleared May 14, 2002
SIMPLICITY QD EASY P INFUSION SET
K021296 · FPA
Sterling Medivations, Inc.
General Hospital · 20d
Cleared May 14, 2002
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
K021308 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 19d
Cleared May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared May 13, 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
K020579 · GEI
Aaron Medical Industries
General & Plastic Surgery · 81d
Cleared May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · MEH
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared May 13, 2002
EVERSTICK ORTHO
K021126 · EBI
Stick Tech , Ltd.
Dental · 35d
Cleared May 13, 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · JDW
Biomet, Inc.
Orthopedic · 28d
Cleared May 13, 2002
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K021226 · KWQ
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared May 13, 2002
SENSAID, MODELS# RC-NVA30-10
K021246 · DQA
Sensidyne, Inc.
Anesthesiology · 24d
Cleared May 13, 2002
MODIFICATION TO 30 EXTENSION SET
K021395 · FPA
Churchill Medical Systems, Inc.
General Hospital · 11d
Cleared May 13, 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · ELW
Dentsply Intl.
Dental · 10d
Cleared May 10, 2002
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013886 · NCS
Advanced Diagnostics, Inc.
Radiology · 168d