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
107833–107856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1994
MEDI STRUMPF
K941926 · DWL
Medi USA, LP
General Hospital · 56d
Cleared Jun 15, 1994
VECTOR POWER WHEELCHAIR
K942075 · ITI
Vector Mobility, Inc.
Physical Medicine · 47d
Cleared Jun 15, 1994
ONGARD 2 GALLON SHARPS CONTAINER
K942323 · FMI
Ongard Systems, Inc.
General Hospital · 33d
Cleared Jun 15, 1994
PREMIER
K942437 · LYY
Premier Medical Industries, Inc.
General Hospital · 26d
Cleared Jun 14, 1994
MX4042/MC4044 SERIES SIMULCATH(TM)
K922323 · KXO
Medex, Inc.
Obstetrics & Gynecology · 771d
Cleared Jun 14, 1994
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE
K922420 · HIH
Linvatec Corp.
Obstetrics & Gynecology · 754d
Cleared Jun 14, 1994
IF400
K930535 · LIH
Skylark Device Co., Ltd.
Neurology · 497d
Cleared Jun 14, 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · LZO
Exactech, Inc.
Orthopedic · 438d
Cleared Jun 14, 1994
TEMPORARY SCREENING LEAD/CATHETER KIT
K934938 · GZB
Medtronic Vascular
Neurology · 239d
Cleared Jun 14, 1994
MINIOX 1000 OXYGEN CONCENTRATION INDICATOR
K935364 · CCL
Minesafety Appliances Co.
Anesthesiology · 222d
Cleared Jun 14, 1994
EXETER ALL PLASTIC ACETABULAR COMPONENT
K936132 · JDI
Howmedica, Inc.
Orthopedic · 173d
Cleared Jun 14, 1994
RELIANT CONSTRICTION RING
K940995 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 102d
Cleared Jun 14, 1994
FIRST AID/TRUMA KIT
K941311 · LRR
Certified Safety Mfg., Inc.
General & Plastic Surgery · 88d
Cleared Jun 14, 1994
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
K941334 · HET
Davol, Inc.
Obstetrics & Gynecology · 88d
Cleared Jun 14, 1994
LL-55 (METHAFILCON A) FOR DAILY WEAR
K941877 · LPL
Lombart Lenses, Ltd.
Ophthalmic · 57d
Cleared Jun 14, 1994
PRESSURE MONITORING EXTENSION
K942482 · DQO
Surgical Technologies, Inc.
Cardiovascular · 20d
Cleared Jun 13, 1994
DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
K924726 · DEH
Dako Corp.
Immunology · 630d
Cleared Jun 13, 1994
SURGICAL DRAPES, MODIFICATION
K931146 · KKX
Amsco Sterile Recoveries, Inc.
General Hospital · 465d
Cleared Jun 13, 1994
ARTHROSCOPE
K931792 · HRH
Intramed Laboratories, Inc.
Ophthalmic · 427d
Cleared Jun 13, 1994
DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
K932136 · DEH
Dako Corp.
Immunology · 406d
Cleared Jun 13, 1994
EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
K933251 · MCD
Virion (U.S.), Inc.
Microbiology · 346d
Cleared Jun 13, 1994
DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH
K933737 · ELM
Durodent Corp.
Dental · 315d
Cleared Jun 13, 1994
UA PERFECT
K935408 · KQO
Chimera Research & Chemical, Inc.
Chemistry · 216d
Cleared Jun 13, 1994
MAC/IV SEDATION KIT
K935546 · BSZ
Vital Signs, Inc.
Anesthesiology · 208d