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
71353–71376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · LPH
Biomet, Inc.
Orthopedic · 86d
Cleared Jun 12, 2003
CONTACT LENS STORAGE CASE
K030987 · LRX
Pelican Products
Ophthalmic · 76d
Cleared Jun 12, 2003
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES...
K030993 · LYY
Sgmp Co., Ltd.
General Hospital · 76d
Cleared Jun 12, 2003
NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH &...
K030994 · LYY
Sgmp Co., Ltd.
General Hospital · 76d
Cleared Jun 12, 2003
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
K031083 · HTY
Opus Medical, Inc.
Orthopedic · 69d
Cleared Jun 12, 2003
PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
K031103 · JWY
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared Jun 12, 2003
PORTA PRESSOVER
K031264 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Jun 11, 2003
RESQPOD CIRCULATORY ENHANCER
K022906 · BWF
Cprx, LLC
Anesthesiology · 281d
Cleared Jun 11, 2003
GALIX PACESTAR
K023080 · DTE
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 267d
Cleared Jun 11, 2003
DISPOSABLE TEMPORARY PACING WIRE
K023174 · LDF
River Medical, Inc.
Cardiovascular · 261d
Cleared Jun 11, 2003
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
K024010 · EZL
The Kendall Company Div. of Tyco...
Gastroenterology & Urology · 189d
Cleared Jun 11, 2003
VECTORVISION FLUORO3D
K024192 · HAW
Brainlab AG
Neurology · 203d
Cleared Jun 11, 2003
PRIME ECG SYSTEM
K030104 · DPS
Meridian Medical Technologies, Inc.
Cardiovascular · 149d
Cleared Jun 11, 2003
EKGCARD SYSTEM
K030535 · DPS
Qrs Diagnostic, LLC
Cardiovascular · 111d
Cleared Jun 11, 2003
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
K030800 · GXY
Eletromed, Inc.
Neurology · 90d
Cleared Jun 11, 2003
IQMARK DIGITAL HOLTER
K031466 · MLO
Brentwood Medical Technology Corp.
Cardiovascular · 34d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 11, 2003
NANO-TICROWN
K031627 · EJH
Nano-Write Corp.
Dental · 15d
Cleared Jun 11, 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · MQB
Canon USA, Inc.
Radiology · 15d
Cleared Jun 10, 2003
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
K021360 · KXK
Med-Tec,Inc.
Radiology · 406d
Cleared Jun 10, 2003
WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE...
K023755 · FXX
Winner Industries (Shenzhen) Co., Ltd.
General Hospital · 214d
Cleared Jun 10, 2003
ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
K024111 · DZE
Astra Tech, Inc.
Dental · 179d
Cleared Jun 10, 2003
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · LYR
Alfa Scientific Designs, Inc.
Microbiology · 162d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS...
K030519 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 111d