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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163393–163416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 29, 1981
HOWMEDICA FEMORAL PRESSURING SEAL
K811317 · KIH
Howmedica Corp.
Orthopedic · 17d
Cleared May 29, 1981
SCHAEDLER BROTH
K811329 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
SIM MEDIUM
K811330 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
SF BROTH
K811331 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
BRAIN HEART CC AGAR
K811332 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
EC MEDIUM
K811333 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 17d