FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
125185–125208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1990
ARGIDENT K GOLD ALLOY FOR PORCELAIN
K903685 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Aug 30, 1990
AVI MODEL 880 DUAL CHANNEL INFUSION PUMP
K903781 · FRN
3M Avi, Inc.
General Hospital · 10d
Cleared Aug 30, 1990
AVI MODEL 480CM INFUSION PUMP
K903784 · FRN
3M Avi, Inc.
General Hospital · 10d
Cleared Aug 30, 1990
AVI MICRO 885 DUAL CHANNEL INFUSION PUMP
K903789 · FRN
3M Avi, Inc.
General Hospital · 10d
Cleared Aug 30, 1990
RAPITEX(R) RF NEW
K903852 · DHR
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Aug 30, 1990
RAPITEX (R) CRP NEW
K903853 · DCN
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Aug 29, 1990
TRACH CARE MDI ADAPTER
K900273 · CAF
Ballard Medical Products
Anesthesiology · 222d
Cleared Aug 29, 1990
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483 · CAC
Baxter Healthcare Corp
Anesthesiology · 209d
Cleared Aug 29, 1990
LASER-SHIELD II(TM)
K901016 · GEX
Xomed, Inc.
General & Plastic Surgery · 177d
Cleared Aug 29, 1990
MODEL 3001 SYRINGE INFUSION PUMP
K901755 · FRN
Medfusion, Inc.
General Hospital · 134d
Cleared Aug 29, 1990
INTERJECTOR BLOOD COLLECTION DEVICE
K901756 · JKA
Bowman/Vector, Inc.
Chemistry · 134d
Cleared Aug 29, 1990
ELANTEC'S SURGICAL TAPE REMOVER
K902009 · KOX
Elantec, Inc.
General & Plastic Surgery · 118d
Cleared Aug 29, 1990
PVC PATIENT EXAMINATION GLOVE
K902278 · FMC
Fujian Province Jiu Zhou Group
General Hospital · 99d
Cleared Aug 29, 1990
HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE
K902402 · EBF
Dentalez Group
Dental · 90d
Cleared Aug 29, 1990
HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE
K902436 · JDI
Zimmer, Inc.
Orthopedic · 90d
Cleared Aug 29, 1990
STERI-CATH-DL
K902687 · BSY
Concord/Portex
Anesthesiology · 71d
Cleared Aug 29, 1990
PATIENT EXAMINATION GLOVE
K902770 · LYY
Mastri Lieno, PT
General Hospital · 69d
Cleared Aug 29, 1990
GRAVITY ASSIST
K902854 · KYZ
Instrument Makar, Inc.
General Hospital · 61d
Cleared Aug 29, 1990
MPS DIAMOND POLISHING GEL
K903003 · EJR
Abrasive Technology, Inc.
Dental · 51d
Cleared Aug 29, 1990
IMMUNOCORP LH IRMA COATED TUBE
K903052 · CEP
Immunocorp Sciences, Inc.
Chemistry · 49d
Cleared Aug 29, 1990
STAT TEST HDL/CHOLESTEROL TEST KIT
K903094 · LBR
Diagnostic Resources, Inc.
Chemistry · 47d
Cleared Aug 29, 1990
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
K903107 · LYY
Ansell, Inc.
General Hospital · 51d
Cleared Aug 29, 1990
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)
K903108 · LYY
Ansell, Inc.
General Hospital · 50d
Cleared Aug 29, 1990
TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
K903306 · JGJ
Technicon Instruments Corp.
Chemistry · 36d