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
104449–104472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1995
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
K945171 · KYG
Boston Surgical Products, Inc.
Ophthalmic · 110d
Cleared Feb 08, 1995
INTRAVASCULAR ADMINISTRATION SET
K945184 · FPK
Distronic Sterile Products, Inc.
General Hospital · 107d
Cleared Feb 08, 1995
CATALOGUE NUMBER 321-07/15/50
K945243 · JFJ
Diagnostic Chemicals , Ltd.
Chemistry · 104d
Cleared Feb 08, 1995
NOVA 16 ANALYZER
K945584 · JJC
Nova Biomedical Corp.
Chemistry · 86d
Cleared Feb 08, 1995
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM)...
K945689 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 79d
Cleared Feb 08, 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
K945951 · JHI
Syntron Bioresearch, Inc.
Chemistry · 64d
Cleared Feb 08, 1995
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
K945963 · DQT
Micro Interventional Systems, Inc.
Cardiovascular · 63d
Cleared Feb 08, 1995
3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS
K946024 · KKX
3M Healthcare
General Hospital · 61d
Cleared Feb 08, 1995
LIQUISPEX(TM) URINE ETHANOL CONTROL
K946144 · JJX
Clinical Controls, Inc.
Toxicology · 54d
Cleared Feb 08, 1995
ACCESS(TM) COMPASS BED
K946244 · LNH
Toshiba America Mri, Inc.
Radiology · 48d
Cleared Feb 08, 1995
VIP
K950080 · ESD
Bell Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 08, 1995
ADVANTX 1824 SPOTFILM DEVICE
K950317 · IXL
GE Medical Systems
Radiology · 13d
Cleared Feb 08, 1995
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
K950319 · ESD
Resound Corp.
Ear, Nose, Throat · 13d
Cleared Feb 07, 1995
KLAAS IOL LENSFOLDER
K930628 · KYB
Bova Intl.
Ophthalmic · 729d
Cleared Feb 07, 1995
MODEL 2231 CO2 INSUFFLATOR
K934884 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 483d
Cleared Feb 07, 1995
LIFESIGN MI MYOGLOBIN
K942052 · DDR
Princeton Biomedix
Immunology · 285d
Cleared Feb 07, 1995
CLINITRON AT HOME AIR FLUIDED THERAPY
K942184 · INX
Ssi Medical Services, Inc.
Physical Medicine · 279d
Cleared Feb 07, 1995
GRAFT THROMBECTOMY INSTRUMENTS
K942457 · MCW
Intramed Laboratories, Inc.
Cardiovascular · 259d
Cleared Feb 07, 1995
CPR SHIELD
K942671 · CBP
Rondex Products, Inc.
Anesthesiology · 246d
Cleared Feb 07, 1995
THERMORESIN LC II
K942993 · EBF
GC America, Inc.
Dental · 232d
Cleared Feb 07, 1995
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
K943879 · FAS
American Urologicals, Inc.
Gastroenterology & Urology · 182d
Cleared Feb 07, 1995
CT PROSPEED FAMILY
K944013 · JAK
GE Medical Systems
Radiology · 175d
Cleared Feb 07, 1995
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
K944391 · FEN
Surgitek
Gastroenterology & Urology · 151d
Cleared Feb 07, 1995
DEXIDE INSUFFLATION TUBING WITH FILTER
K944509 · HIF
Dexide, Inc.
Obstetrics & Gynecology · 145d