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
106801–106824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1994
CONBIO MEDALEX LASER SYSTEM
K935631 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 272d
Cleared Aug 23, 1994
ELITE PUTTY SOFT
K935884 · ELW
Zhermack Dental Production
Dental · 315d
Cleared Aug 23, 1994
ELITE FAST PUTTY SOFT
K935885 · ELW
Zhermack Dental Production
Dental · 315d
Cleared Aug 23, 1994
ELITE LIGHT BODY
K935886 · ELW
Zhermack Dental Production
Dental · 315d
Cleared Aug 23, 1994
ELITE REGULAR BODY
K935887 · ELW
Zhermack Dental Production
Dental · 315d
Cleared Aug 23, 1994
ELITE FAST LIGHT BODY
K935888 · ELW
Zhermack Dental Production
Dental · 315d
Cleared Aug 23, 1994
OCCLUFAST
K935889 · ELW
Zhermack Dental Production
Dental · 315d
Cleared Aug 23, 1994
PEREGRINE PIC MINIPULATOR
K940392 · KYG
Peregrine Surgical , Ltd.
Ophthalmic · 209d
Cleared Aug 23, 1994
HISPEED ADVANTAGE II
K940606 · JAK
GE Medical Systems
Radiology · 194d
Cleared Aug 23, 1994
INNERVISION,INC. LAPAROSCOPIC ELECTRODES
K940750 · GEI
Innervision, Inc.
General & Plastic Surgery · 186d
Cleared Aug 23, 1994
ACCESS
K940796 · LNH
Toshiba America Mri, Inc.
Radiology · 182d
Cleared Aug 23, 1994
ENDOPATH OPTICAL OBTURATOR AND SLEEVE
K941027 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 172d
Cleared Aug 23, 1994
FLARED PATCH
K941299 · FTL
Flared Patch, Inc.
General & Plastic Surgery · 159d
Cleared Aug 23, 1994
EMPI TAPE PATCHES
K941389 · KGX
Empi
General & Plastic Surgery · 154d
Cleared Aug 23, 1994
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
K941661 · EQH
Gm Engineering, Inc.
Ear, Nose, Throat · 140d
Cleared Aug 23, 1994
SHARPS-TAINER
K942054 · FMI
Winfield Industries
General Hospital · 117d
Cleared Aug 23, 1994
TONGUE SCRAPER
K942076 · LCN
Maharishi Ayur-Ved
Dental · 116d
Cleared Aug 23, 1994
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K942212 · LYC
Ceramed Corp.
Dental · 109d
Cleared Aug 23, 1994
IMEXDOP CT+
K942441 · JAF
Imex Medical Systems, Inc.
Radiology · 92d
Cleared Aug 23, 1994
MEDCUFF
K942488 · DXQ
Med-Con, Inc.
Cardiovascular · 90d
Cleared Aug 23, 1994
UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS
K942519 · ECB
Bull Frog Mfg. Co.
Dental · 89d
Cleared Aug 23, 1994
SUNGLASSES
K942531 · HQY
Lumen S.R.L.
Ophthalmic · 88d
Cleared Aug 23, 1994
TRIMPORT
K942623 · LJT
Gerard Medical Enterprises, Inc.
General Hospital · 88d
Cleared Aug 23, 1994
ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE
K942727 · DYH
Wallace A. Erickson & Co.
Dental · 75d