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
81793–81816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2000
PHARMASEED, MODEL BT-125-2
K993701 · KXK
Syncor International, Inc.
Radiology · 220d
Cleared Jun 09, 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR...
K994199 · KKX
Custom Medical Products, Inc.
General Hospital · 179d
Cleared Jun 08, 2000
UNIVEC TWO PIECE SYRINGE
K000747 · FMF
Univec, Inc.
General Hospital · 93d
Cleared Jun 08, 2000
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX,...
K000792 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 08, 2000
TALON BALLOON DILATION CATHETER
K000798 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · LZA
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
K000815 · MHX
Datex-Ohmeda
Cardiovascular · 87d
Cleared Jun 08, 2000
OMEGA II MODULAR TOTAL HIP SYSTEM
K000817 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 87d
Cleared Jun 08, 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · JEY
Bionx Implants, Inc.
Dental · 86d
Cleared Jun 08, 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · FRN
Sims Deltec, Inc.
General Hospital · 85d
Cleared Jun 08, 2000
PENADAPT 10
K000904 · FYD
Buffalo Filter Co., Inc.
General Hospital · 79d
Cleared Jun 08, 2000
AU5 ULTRASOUND IMAGING SYSTEM
K000931 · IYN
Biosound Esaote, Inc.
Radiology · 78d
Cleared Jun 08, 2000
SPERM WASH MEDIUM, CAT# 2003/2005
K000989 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 72d
Cleared Jun 08, 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · KWS
Biopro, Inc.
Orthopedic · 69d
Cleared Jun 08, 2000
L720 EXAMINATION CHAIR
K001261 · KNC
Luneau Gynecologie SA
Obstetrics & Gynecology · 50d
Cleared Jun 08, 2000
AIRDENT II CS
K001313 · KOJ
Air Technologies, Inc.
Dental · 43d
Cleared Jun 08, 2000
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K001377 · LTZ
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 38d
Cleared Jun 08, 2000
ALLON 2001
K001546 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 21d
Cleared Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN...
K001602 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Jun 08, 2000
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
K991137 · DTR
Minntech Corp.
Cardiovascular · 430d
Cleared Jun 08, 2000
ENGAGE JAW INSERTS
K992980 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 279d
Cleared Jun 08, 2000
TRI-BALL
K994074 · BWF
Leventon, S.A.
Anesthesiology · 189d
Cleared Jun 07, 2000
MDA D-DIMER
K000492 · DAP
Organon Teknika Corp.
Hematology · 113d
Cleared Jun 07, 2000
QUANTA LITE LKM-1 ELISA
K000535 · NBS
Inova Diagnostics, Inc.
Immunology · 111d