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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134521–134544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM) NO. 210-3512
K882863 · KIT
J R Scientific
Pathology · 21d
Cleared Jul 29, 1988
GENT-L-KARE STERILE URINARY LEG BAG
K881217 · KNX
Geneva Laboratories, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 29, 1988
SET, INTRAVASCULAR
K881975 · FPA
Primrose Medical, Inc.
General Hospital · 79d
Cleared Jul 29, 1988
PRESSURE INFUSOR
K881977 · KZD
Primrose Medical, Inc.
General Hospital · 79d
Cleared Jul 29, 1988
A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED
K882230 · LJT
Therex Corp.
General Hospital · 63d
Cleared Jul 29, 1988
STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC
K882240 · GDM
Storz Instrument Co.
General & Plastic Surgery · 63d
Cleared Jul 29, 1988
BOLDREY PERIPHERAL RETINAL LENS
K882574 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 37d
Cleared Jul 29, 1988
NEOLENS SUNGLASSES
K882813 · HQY
Neolens, Inc.
Ophthalmic · 21d
Cleared Jul 29, 1988
NEOLENS PRESCRIPTION SPECTACLE LENS
K882814 · HQG
Neolens, Inc.
Ophthalmic · 21d
Cleared Jul 28, 1988
MODIFIED MODEL SSD-650 SYSTEM
K873452 · IYO
Ge Medical Systems Information...
Radiology · 336d
Cleared Jul 28, 1988
MODIFIED PERIPHERAL DILATATION CATHETERS
K875175 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 224d
Cleared Jul 28, 1988
MEDRAD OPEN ENDED GUIDEWIRE
K880332 · DQX
Medrad, Inc.
Cardiovascular · 184d
Cleared Jul 28, 1988
CORDIS PTA DILATATION CATHETERS
K880612 · LIT
Cordis Corp.
Cardiovascular · 163d
Cleared Jul 28, 1988
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K880933 · CEP
Amersham Corp.
Chemistry · 143d
Cleared Jul 28, 1988
MODEL BPS08 BLOOD PRESSURE MODULE
K881155 · DXN
Fresenius USA, Inc.
Cardiovascular · 132d
Cleared Jul 28, 1988
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
K881213 · KNX
Geneva Laboratories, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 28, 1988
GENT-L-KARE CLEANSING ENEMA SET
K881218 · FCE
Geneva Laboratories, Inc.
Gastroenterology & Urology · 128d
Cleared Jul 28, 1988
BAGGISH, HYSTEROSCOPE
K881249 · HIH
Bryan Corp.
Obstetrics & Gynecology · 127d
Cleared Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
K881816 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 91d
Cleared Jul 28, 1988
CATHETER WITHDRAWAL UNIT
K881878 · KNY
Eris Medical Technology
Gastroenterology & Urology · 85d
Cleared Jul 28, 1988
HARBOR CENTRAL VENOUS CATHETER
K881884 · DQR
Harbor Medical Devices, Inc.
Cardiovascular · 85d