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
100681–100704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1995
INFINITECH LIGHTED INFUSION CANNULA
K946136 · MPA
Surgical Technologies, Inc.
Ophthalmic · 290d
Cleared Oct 02, 1995
QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728 · DHB
Quidel Corp.
Immunology · 228d
Cleared Oct 02, 1995
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · MID
Elias U.S.A., Inc.
Immunology · 200d
Cleared Oct 02, 1995
IV START KIT
K953474 · FPA
Medikmark, Inc.
General Hospital · 70d
Cleared Oct 02, 1995
VASPORT VASCULAR ACCESS PORT
K953571 · LJT
Gish Biomedical, Inc.
General Hospital · 63d
Cleared Oct 02, 1995
ULTRA-SENSITIVE ESTRADIOL
K953605 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 61d
Cleared Oct 02, 1995
STERIMED STERIZATION WRAPPER (NON-STERILE)
K953678 · FRG
Customed, Inc.
General Hospital · 56d
Cleared Oct 02, 1995
PALASPLINT
K953743 · EBI
Heraeus Kulzer, Inc.
Dental · 54d
Cleared Oct 02, 1995
GAUZE SPONGE
K953812 · KHR
Remington Medical, Inc.
Dental · 61d
Cleared Oct 02, 1995
SNOREMASTER
K954128 · LRK
D.D.S., Inc.
Dental · 31d
Cleared Oct 02, 1995
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
K954278 · MMZ
Beta Medical Products, Inc.
Gastroenterology & Urology · 19d
Cleared Sep 29, 1995
MYOTRAC2D/CS
K925681 · HIR
Thought Technology , Ltd.
Gastroenterology & Urology · 1081d
Cleared Sep 29, 1995
STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ
K940600 · GZJ
Progressive Concepts, Inc.
Neurology · 596d
Cleared Sep 29, 1995
MULLAN GANGLION MICROCOMPRESSION SET
K940973 · HAO
Cook, Inc.
Neurology · 575d
Cleared Sep 29, 1995
SUPRASSON P MAX
K942139 · ELC
Satelec
Dental · 514d
Cleared Sep 29, 1995
NORTHGATE FLOW ASSIST TUBING FOR UROLOGY
K943361 · LJH
Northgate Technologies, Inc.
Gastroenterology & Urology · 443d
Cleared Sep 29, 1995
CIT BIOPSY PUNCHES
K944444 · HFB
Chirurgische Instrumente
Obstetrics & Gynecology · 413d
Cleared Sep 29, 1995
REUSABLE ALL - GLASS SYRINGES
K944542 · FMF
Top Syringe Mfg. Co.
General Hospital · 378d
Cleared Sep 29, 1995
EASTERCLAVE
K951557 · FLE
Easter Services, Inc.
General Hospital · 178d
Cleared Sep 29, 1995
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER
K951738 · FOS
Sherwood Medical Co.
General Hospital · 168d
Cleared Sep 29, 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · DXY
Biotronik, Inc.
Cardiovascular · 134d
Cleared Sep 29, 1995
RETRAC
K952728 · ELW
Centrix, Inc.
Dental · 107d
Cleared Sep 29, 1995
SKIN SAVER SYSTEMS
K952738 · FQM
Skin Saver Systems, Inc.
General Hospital · 107d
Cleared Sep 29, 1995
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
K952743 · CIT
Medical Diagnostic Technologies, Inc.
Chemistry · 105d