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

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175,820 results
132433–132456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1989
HEMATASTAT H-70
K890849 · GKG
Separation Technology, Inc.
Hematology · 28d
Cleared Mar 21, 1989
LATEX EXAMINATION GLOVES
K891204 · LYY
Advance Rubber, Inc.
General Hospital · 15d
Cleared Mar 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891208 · LYY
Cho FU Industrial Co., Ltd.
General Hospital · 15d
Cleared Mar 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891242 · LYY
Dr. Boo Co., Ltd.
General Hospital · 14d
Cleared Mar 20, 1989
10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC
K882274 · DSP
Kontron Instruments, Inc.
Cardiovascular · 293d
Cleared Mar 20, 1989
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
K882508 · DSP
Kontron Instruments, Inc.
Cardiovascular · 276d
Cleared Mar 20, 1989
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
K890011 · BZO
Life Design Systems, Inc.
Anesthesiology · 76d
Cleared Mar 20, 1989
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
K890708 · JJY
Amersham Corp.
Chemistry · 48d
Cleared Mar 20, 1989
DMA MICROPROTEIN PROCEDURE
K890868 · CEK
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Mar 17, 1989
ADMS SILENT NEEDLE GUN
K882746 · KNW
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 255d
Cleared Mar 17, 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · ELW
Dentsply Intl.
Dental · 186d
Cleared Mar 17, 1989
BRACKET TABLE ARM COVER
K884219 · EIA
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
AIR WATER SYRINGE TIP SHIELD
K884220 · EFS
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
ULTRASONIC SCALER COVER
K884221 · ELC
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
CURING LIGHT COVER
K884222 · EBZ
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
DENTAL LAMP HANDLE COVER
K884223 · EAZ
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
TORAY FILTRYZER DIALYZERS
K884339 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 154d
Cleared Mar 17, 1989
COLONOSCOPE GUIDING TUBE DEVICE
K884857 · FDF
Mill-Rose Laboratory
Gastroenterology & Urology · 116d
Cleared Mar 17, 1989
HEMOSORBA CH-500, CH-350 AND CH-180
K885017 · FLD
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Mar 17, 1989
MASSAGING PICK FOR ORAL HYGIENE
K885189 · JET
Dentek Corp.
Dental · 91d
Cleared Mar 17, 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · GCX
Abbott Laboratories
General Hospital · 88d
Cleared Mar 17, 1989
AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*
K890270 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 58d
Cleared Mar 17, 1989
THE CLARK LIP SHIELD
K890581 · EJF
American Orthodontics
Dental · 39d
Cleared Mar 17, 1989
HOOD NASAL SPLINT
K890599 · EPP
Hood Laboratories
Ear, Nose, Throat · 39d