FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86377–86400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1999
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
K983982 · KGO
Maxxim Medical
General Hospital · 176d
Cleared May 04, 1999
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
K984249 · LZA
London International Group, Inc.
General Hospital · 155d
Cleared May 04, 1999
DBC, DONG BANG ACUPUNCTURE NEEDLES
K990328 · MQX
Morning Star, Dong Bang Acupuncture...
General Hospital · 91d
Cleared May 04, 1999
ORALGIENE TONGUE CLEANER
K990344 · LCN
Oralgiene USA, Inc.
Dental · 89d
Cleared May 04, 1999
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990575 · LZA
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990577 · LZA
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990686 · LYY
Tower Rubber Industries Sdn. Bhd.
General Hospital · 62d
Cleared May 04, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
K990695 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 62d
Cleared May 04, 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN...
K990702 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 62d
Cleared May 04, 1999
EDGE SYSTEMS STERILE TUBING
K990748 · GEX
Edge Systems Corp.
General & Plastic Surgery · 57d
Cleared May 04, 1999
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50...
K990812 · LYY
Ampri Rubberware Industries Sdn Bhd
General Hospital · 54d
Cleared May 04, 1999
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509...
K990829 · MCW
Arrow Intl., Inc.
Cardiovascular · 53d
Cleared May 04, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990901 · LYY
Apl Products Sdn. Bhd.
General Hospital · 47d
Cleared May 04, 1999
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
K990946 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 43d
Cleared May 04, 1999
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
K991043 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 36d
Cleared May 04, 1999
SAS HCG-CHECK
K991193 · LCX
Sa Scientific, Inc.
Chemistry · 26d
Cleared May 03, 1999
HEMOCHRON RESPONSE
K983475 · KQG
International Technidyne Corp.
Hematology · 213d
Cleared May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 194d
Cleared May 03, 1999
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
K990376 · KNS
Ballard Medical Products
Gastroenterology & Urology · 84d
Cleared May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704 · DCK
Beckman Coulter, Inc.
Immunology · 60d
Cleared Apr 30, 1999
EXTRACORPOREAL BLOOD CIRCUIT
K982340 · FJK
Haidylena Medical Egypt
Gastroenterology & Urology · 298d
Cleared Apr 30, 1999
SILK SUTURE
K982853 · GAP
Davis & Geck, Inc.
General & Plastic Surgery · 260d
Cleared Apr 30, 1999
SINGLE AXLE TOTAL ELBOW
K983036 · JDC
Biomet, Inc.
Orthopedic · 242d
Cleared Apr 30, 1999
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM...
K983610 · CAH
Intersurgical, Inc.
General Hospital · 198d