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
71857–71880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2003
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K031021 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 74d
Cleared Jun 13, 2003
CARESTART HCG ONE-STEP PREGNANCY TEST
K031052 · DHA
Access Bio Incorporate
Chemistry · 72d
Cleared Jun 13, 2003
CORD STICK MULTIPLE DRAW SYSTEM
K031058 · FMI
Cord Stick Corp.
General Hospital · 71d
Cleared Jun 13, 2003
PASCO MIC AND MIC/ID PANELS
K031205 · JWY
Pasco Laboratories, Inc.
Microbiology · 58d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 12, 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
K023559 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 232d
Cleared Jun 12, 2003
SINGLE USE ORAL MASK, MODEL HC455A
K023670 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 224d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · KWP
Blackstone Medical, Inc.
Orthopedic · 142d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608 · JDK
Osteoimplant Technology, Inc.
Orthopedic · 106d
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