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
99313–99336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1996
INNOFLUOR PHENYTOIN ASSAY SYSTEM
K955562 · LGR
Oxis Intl., Inc.
Toxicology · 49d
Cleared Jan 24, 1996
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
K955567 · LGS
Oxis Intl., Inc.
Toxicology · 49d
Cleared Jan 24, 1996
U-TEX
K955810 · FHA
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 29d
Cleared Jan 23, 1996
KLORMAN
K923693 · LRJ
Matrix Medica, Inc.
General Hospital · 1279d
Cleared Jan 23, 1996
I.V. ADMINISTRATION SET CONNECTING DEVICE
K940832 · FPA
Sierra Medical Devices
General Hospital · 699d
Cleared Jan 23, 1996
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
K952515 · JBQ
Chromogenix AB
Hematology · 237d
Cleared Jan 23, 1996
BODY FLUID BARRIER KIT
K952961 · FXX
Lhb Industries, Inc.
General Hospital · 211d
Cleared Jan 23, 1996
OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
K953068 · KCT
Oxboro Medical Intl., Inc.
General Hospital · 207d
Cleared Jan 23, 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
K953335 · FOZ
Micro Therapeutics, Inc.
General Hospital · 190d
Cleared Jan 23, 1996
NIOMED SURGICAL HOOD
K954454 · FYF
Amerasia Corp.
General & Plastic Surgery · 120d
Cleared Jan 23, 1996
NIOMED BOUFFANT CAPS
K954455 · FYF
Amerasia Corp.
General & Plastic Surgery · 120d
Cleared Jan 23, 1996
ZCH ALPHA SYSTEM
K954744 · JDI
Zimmer, Inc.
Orthopedic · 99d
Cleared Jan 23, 1996
EXTENSION SET WITH CHECK VALVE
K954983 · FPA
Distronic Sterile Products, Inc.
General Hospital · 84d
Cleared Jan 23, 1996
MINIBORE STOPCOCK SET
K954984 · FMG
Distronic Sterile Products, Inc.
General Hospital · 84d
Cleared Jan 23, 1996
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM
K955029 · LYY
Shen Wei (Usa), Inc.
General Hospital · 82d
Cleared Jan 23, 1996
NULIFE
K955055 · LYY
Med-Tech Rubber & Engineering Industries
General Hospital · 81d
Cleared Jan 23, 1996
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K955096 · LYC
Lifecore Biomedical, Inc.
Dental · 77d
Cleared Jan 23, 1996
MAXI-FLOW
K955150 · BYY
Bio-Medical Devices, Inc.
General Hospital · 71d
Cleared Jan 23, 1996
OPAKER
K955337 · EBF
Kerr Dental Materials Center
Dental · 63d
Cleared Jan 23, 1996
MEMFIX
K955369 · DZL
The Straumann Co.
Dental · 60d
Cleared Jan 23, 1996
BALL ATTACHMENT SYSTEM
K955372 · DZE
Nobelpharma USA, Inc.
Dental · 62d
Cleared Jan 23, 1996
GRIP-A-BOOTS
K955463 · LXZ
Sil-Med Corp.
General & Plastic Surgery · 55d
Cleared Jan 22, 1996
FORMALIN REUSE CART
K941757 · LIF
National Medical Care, Medical...
Gastroenterology & Urology · 654d
Cleared Jan 22, 1996
RENALIN REUSE CART
K941867 · LIF
Renal Scientific Service, Inc.
Gastroenterology & Urology · 644d