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
107689–107712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1994
VERRES NEEDLE
K942484 · FHO
Linvatec Corp.
Gastroenterology & Urology · 30d
Cleared Jun 23, 1994
PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO
K926101 · DZE
Phoenix Dental, Inc.
Dental · 567d
Cleared Jun 23, 1994
CATH BELT PD CATHETER AND TRANSFER SET HOLDER
K930175 · FJS
Tabex Industries, Inc.
Gastroenterology & Urology · 526d
Cleared Jun 23, 1994
VINYL EXAMINATION GLOVES (NON STERILE)
K934536 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 276d
Cleared Jun 23, 1994
C450/C400 INFANT INCUBATORS
K940975 · FMZ
Air-Shields, Inc.
General Hospital · 112d
Cleared Jun 23, 1994
BOSTON VII
K942365 · HQD
Polymer Technology Corp.
Ophthalmic · 37d
Cleared Jun 23, 1994
GENESIS
K942553 · FTD
Burton Medical Products Corp.
General & Plastic Surgery · 23d
Cleared Jun 23, 1994
PUTMAN STABILIZER
K942584 · GCJ
J. Michael Putman, M.D., P.A.
General & Plastic Surgery · 22d
Cleared Jun 22, 1994
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K924589 · DZE
Implant Support Systems, Inc.
Dental · 650d
Cleared Jun 22, 1994
PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN
K926102 · DZE
Phoenix Dental, Inc.
Dental · 566d
Cleared Jun 22, 1994
JACE MODEL H440 HAND CPM DEVICE
K931016 · JFA
Jace Systems, Inc.
Physical Medicine · 481d
Cleared Jun 22, 1994
ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.
K933059 · BXB
Jace Systems, Inc.
Physical Medicine · 365d
Cleared Jun 22, 1994
ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)
K934668 · DZE
Zest Anchors, Inc.
Dental · 266d
Cleared Jun 22, 1994
COMFIT GREEN POWDERED EXAMINATION GLOVES
K936265 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 174d
Cleared Jun 22, 1994
COMFIT PINK POWDERED EXAMINATION GLOVES
K936267 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 174d
Cleared Jun 22, 1994
PRO-SHIATSU PORTABLE MASSAGER
K940621 · ISA
Westminster International Co., Inc.
Physical Medicine · 128d
Cleared Jun 22, 1994
PROVOX(TM) VOICE PROSTHESIS
K940638 · EWL
Atos Medical AB
Ear, Nose, Throat · 128d
Cleared Jun 22, 1994
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K940704 · GXY
Conmedcorp
Neurology · 126d
Cleared Jun 22, 1994
ZIPPREP ELECTRODE
K940802 · DRX
Aspect Medical Systems, Inc.
Cardiovascular · 120d
Cleared Jun 22, 1994
IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
K940897 · FPA
Y
General Hospital · 118d
Cleared Jun 22, 1994
SCIMED TRIGUIDE GUIDING CATHETER
K941137 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 104d
Cleared Jun 22, 1994
PULSE OXIMETER
K941289 · DQA
Bci Intl., Inc.
Anesthesiology · 97d
Cleared Jun 22, 1994
SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE
K941426 · GEI
Symbiosis Corp.
General & Plastic Surgery · 90d
Cleared Jun 22, 1994
KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT
K941493 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 86d