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
118201–118224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1992
GOLDLENS(TM)
K913239 · HLZ
Doran Instruments, Inc.
Ophthalmic · 193d
Cleared Jan 31, 1992
HEMOPLUS
K913622 · KHE
Sarstedt, Inc.
Hematology · 170d
Cleared Jan 31, 1992
ASRA, SCREENING AUDIOMETER
K914232 · EWO
Mercury Electronics (Scot) , Ltd.
Ear, Nose, Throat · 133d
Cleared Jan 31, 1992
PULSE RATE MONITOR
K914595 · DPZ
Fitness Quest, Inc.
Anesthesiology · 107d
Cleared Jan 31, 1992
SIL-K
K914701 · MDA
Degania Silicone , Ltd.
General & Plastic Surgery · 105d
Cleared Jan 31, 1992
DERMAPROOF
K914840 · FRO
Pharmalett Medical Care, Holland B.V.
General & Plastic Surgery · 98d
Cleared Jan 31, 1992
DRESSING CHANGE KIT
K914927 · LYY
Westmark Hospital Supplies
General Hospital · 88d
Cleared Jan 31, 1992
LACERATION TRAY
K914929 · KKX
Westmark Hospital Supplies
General Hospital · 88d
Cleared Jan 31, 1992
SUTURE REMOVAL KIT
K914932 · FRG
Westmark Hospital Supplies
General Hospital · 88d
Cleared Jan 31, 1992
HEART PACK III
K914933 · KOD
Westmark Hospital Supplies
Gastroenterology & Urology · 88d
Cleared Jan 31, 1992
HEART PACK II
K914935 · LRO
Westmark Hospital Supplies
General & Plastic Surgery · 88d
Cleared Jan 31, 1992
PERRY(R) CUT-RESISTANT GLOVES
K914942 · LYY
Smith & Nephew Perry
General Hospital · 88d
Cleared Jan 31, 1992
CARRINGTON WOUND DRESSING 4X4(TM)
K915001 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 85d
Cleared Jan 31, 1992
STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS
K915002 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 85d
Cleared Jan 31, 1992
PROACT CLA-1500 SYSTEM
K915061 · FNM
Clinical Systems, Inc.
General Hospital · 84d
Cleared Jan 31, 1992
MITEK SNAP PAK(TM), MODIFICATION
K915081 · GAS
Mitek Surgical Products, Inc.
General & Plastic Surgery · 80d
Cleared Jan 31, 1992
PONTOR MPF,V-GNATHOS PF,24K CASTING GOLD
K915111 · EJT
Metalor Dental USA Corp.
Dental · 79d
Cleared Jan 31, 1992
HOWMEDICA ALUMINA FEMORAL HEAD
K915184 · LZO
Pfizer Hospital Products Group, Inc.
Orthopedic · 74d
Cleared Jan 31, 1992
D-DIMER WELLCOTEST (HA10)
K915203 · DAP
Wellcome Diagnostics
Hematology · 74d
Cleared Jan 31, 1992
NATURAL-KNEE TIBIAL AND FEMORAL SPACERS
K915240 · HSX
Intermedics Orthopedics
Orthopedic · 71d
Cleared Jan 31, 1992
COGAN CORP KITS OF DENTAL HAND INSTRUMENTS
K915299 · EGG
Cogan Corp.
Dental · 73d
Cleared Jan 31, 1992
ADS-GEL AND INSULATING-GEL
K915355 · EBF
Heraeus Kulzer, Inc.
Dental · 66d
Cleared Jan 31, 1992
SR-IVOCAP PLUS
K915377 · EBI
Ivoclar North America, Inc.
Dental · 63d
Cleared Jan 31, 1992
AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE
K915489 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 56d