Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
164233–164256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1981
MINISTIM
K811224 · GZJ
Medical Design & Manufacturing Corp.
Neurology · 29d
Cleared Jun 02, 1981
MODEL 560 SERIES VOLUMETRIC INFUSION
K811238 · FRN
Y
General Hospital · 29d
Cleared Jun 02, 1981
RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)
K811265 · BZQ
Impact Instrumentation, Inc.
Anesthesiology · 21d
Cleared Jun 02, 1981
EXTENDED TUMOR CALIPER
K811278 · FTY
Mick Radio-Nuclear Instruments, Inc.
General & Plastic Surgery · 25d
Cleared Jun 02, 1981
FLEX-TEMPLATE
K811280 · KDC
Mick Radio-Nuclear Instruments, Inc.
General & Plastic Surgery · 25d
Cleared Jun 02, 1981
TEGADERM TRANSPARENT DRESSING
K811291 · KGX
3M Company
General & Plastic Surgery · 22d
Cleared Jun 02, 1981
PARALLEL PLATE DIALYZER HOLDER
K811292 · FKI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 22d
Cleared Jun 02, 1981
SKYTRON ELITE SURGICAL TABLES
K811311 · GBC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 22d
Cleared Jun 02, 1981
CAL-3 CALIBRATED RADIOACTIVITY ASSAYER
K811320 · KPT
Dosimeter Corp.
Radiology · 21d
Cleared Jun 02, 1981
PERCUTANEOUS DRAINING CATHETER
K811378 · GBW
Medi-Tech, Inc.
General & Plastic Surgery · 18d
Cleared Jun 02, 1981
ARGYLE CPAP NASAL CANNULA
K811409 · BZD
Sherwood Medical Co.
Anesthesiology · 14d
Cleared Jun 02, 1981
DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR
K811413 · CAI
Airco/Ohio Medical Products
Anesthesiology · 14d
Cleared Jun 02, 1981
BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM
K811452 · HAW
Trent Wells, Inc.
Neurology · 11d
Cleared Jun 01, 1981
STERILEDGE SELF SEAL POUCH
K810469 · KCT
Beacon Converters, Inc.
General Hospital · 98d
Cleared Jun 01, 1981
TENS-O-MATIC
K811012 · GZJ
O-Matic, Inc.
Neurology · 47d
Cleared May 29, 1981
TAN DEM* - IGE KIT
K802913 · DGC
Hybritech, Inc.
Chemistry · 192d
Cleared May 29, 1981
ELA MEDICAL UNILITH PULSE GENERATOR
K810142 · DXY
Ela Medical, Inc.
Cardiovascular · 128d
Cleared May 29, 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · FPA
Abbott Laboratories
General Hospital · 121d
Cleared May 29, 1981
MULTILITH PULSE GENERATOR #1140
K810489 · DXY
Ela Medical, Inc.
Cardiovascular · 95d
Cleared May 29, 1981
CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT
K810853 · CGS
The Upjohn Co.
Chemistry · 60d
Cleared May 29, 1981
ALPHA-THAL SCREEN TM CONTROL
K810976 · LGL
Isolab, Inc.
Chemistry · 49d
Cleared May 29, 1981
CAMPBRIDGE COMPUTRACE
K811062 · DXG
Cambridge Instruments, Inc.
Cardiovascular · 42d
Cleared May 29, 1981
T3 (RIA) KIT
K811213 · CDP
Immuno Assay Corp.
Chemistry · 25d
Cleared May 29, 1981
TOX TM ANALYZER
K811263 · JQZ
Abbott Laboratories
Immunology · 23d