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
146161–146184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1985
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
K853569 · BYX
Medipart Jerry Alexander
Anesthesiology · 73d
Cleared Nov 07, 1985
MEDIPART DRIERITE MP-1002
K853570 · IYT
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M
K853576 · IYT
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
K853579 · IYT
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
ALLERG-E IGE ENZYME IMMUNOASSAY KIT
K853607 · DGO
Dexall Biomedical Labs, Inc.
Immunology · 71d
Cleared Nov 07, 1985
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS
K853630 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 69d
Cleared Nov 07, 1985
UNITRON MODEL UM60-D
K853780 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 07, 1985
UNITRON MODEL UM60-PP
K853781 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 07, 1985
GOLDEN CERAMIC
K853982 · EJT
Wiliams Gold Refining Co., Inc.
Dental · 41d
Cleared Nov 07, 1985
RESIN TRAY IMPRESSION MATERIAL
K854042 · EBH
Dentsply Intl.
Dental · 36d
Cleared Nov 07, 1985
PALL PULMONARY FUNCTION FILTER
K854062 · BZG
Pall Biomedical Products Co.
Anesthesiology · 34d
Cleared Nov 06, 1985
LAP-CATH
K852197 · DQO
Research Medical, Inc.
Cardiovascular · 170d
Cleared Nov 06, 1985
NOVAMETRIX PULSE OXIMETER, MODEL 500
K853124 · JOM
Novametrix Medical Systems, Inc.
Cardiovascular · 104d
Cleared Nov 06, 1985
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K853134 · FRN
Erika, Inc.
General Hospital · 103d
Cleared Nov 06, 1985
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · LJT
Medtronic Vascular
General Hospital · 90d
Cleared Nov 06, 1985
DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY
K853513 · FKP
Cd Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 06, 1985
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
K853830 · LHI
Travenol Laboratories, S.A.
General Hospital · 54d
Cleared Nov 06, 1985
MVM 4000 HOLTER IV RECORDER
K853985 · DSH
Mountain View Medical
Cardiovascular · 40d
Cleared Nov 06, 1985
GUIDING CATHETER
K853998 · DQY
Target Therapeutics
Cardiovascular · 37d
Cleared Nov 06, 1985
SNAP-LOCK ADDITIVE CAP #SL100
K854031 · KPE
Williams Medical Co.
General Hospital · 36d
Cleared Nov 06, 1985
SNAP-LOCK ADDITIVE CAP #SL400
K854033 · KPE
Williams Medical Co.
General Hospital · 36d
Cleared Nov 06, 1985
SNAP-LOCK ADDITIVE CAP #SL 300
K854034 · KPE
Williams Medical Co.
General Hospital · 36d
Cleared Nov 06, 1985
I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
K854171 · FTC
Intl. Solarium Manufacturer, Inc.
General & Plastic Surgery · 22d
Cleared Nov 05, 1985
ENZYGNOST ANTIHERPES SIMPLEX VIRUS
K841245 · GQO
Behring Diagnostics, Inc.
Immunology · 592d