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
125425–125448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1990
GENERAL ELECTRIC AMX 3
K902610 · IZL
Pro-Tronics, Inc.
Radiology · 20d
Cleared Jun 29, 1990
RUBBER CONTRACEPTIVE
K896107 · HIS
Banrub Sdn Bhd
Obstetrics & Gynecology · 249d
Cleared Jun 29, 1990
BIOPSY FORCEPS
K901300 · DWZ
Portlyn Corp.
Cardiovascular · 101d
Cleared Jun 29, 1990
NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
K901499 · GZB
Neuromed, Inc.
Neurology · 92d
Cleared Jun 29, 1990
ACKRAD MPR DRAINAGE CATHETER SET
K901574 · KNT
Ackrad Laboratories
Gastroenterology & Urology · 87d
Cleared Jun 29, 1990
SULLIVAN VARIABLE STIFFNESS CABLE
K901610 · FDF
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 29, 1990
CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM
K901782 · EBH
Productivity Training Corp.
Dental · 73d
Cleared Jun 29, 1990
ZEPPELIN FORCEPS
K901897 · HCZ
Kirwan Surgical Products, Inc.
Obstetrics & Gynecology · 65d
Cleared Jun 29, 1990
ADD'L USE OF THE KTP/YAG SURGICAL LASER
K902058 · GEX
Laserscope
General & Plastic Surgery · 53d
Cleared Jun 29, 1990
NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM
K902063 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 57d
Cleared Jun 29, 1990
CUFF, BLOOD PRESSURE
K902132 · DXQ
Buffalo Medical Specialties Mfg., Inc.
Cardiovascular · 50d
Cleared Jun 29, 1990
SURGILASE YAG 100 SURGICAL LASER SYSTEM
K902211 · GEX
Surgilase, Inc.
General & Plastic Surgery · 50d
Cleared Jun 29, 1990
SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM
K902535 · JAA
Sony Medical Electronics Co.
Radiology · 21d
Cleared Jun 29, 1990
LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH
K902603 · ILJ
Unique Bathing Supplies, Inc.
Physical Medicine · 17d
Cleared Jun 29, 1990
GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
K902656 · HET
Gynescope Corp.
Obstetrics & Gynecology · 14d
Cleared Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
K895437 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 293d
Cleared Jun 28, 1990
DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)
K896582 · LCP
Primus, Inc.
Chemistry · 223d
Cleared Jun 28, 1990
CORE-VENT ARMENTARIUM
K900177 · DZE
Core-Vent Corp.
Dental · 163d
Cleared Jun 28, 1990
PACEMAKER PATIENT ADAPTOR MODULE (PPAM)
K900213 · DSB
Bomed Medical Mfg., Ltd.
Cardiovascular · 162d
Cleared Jun 28, 1990
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
K900319 · DSI
Siemens Medical Electronics
Cardiovascular · 156d
Cleared Jun 28, 1990
INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM
K900549 · DZE
Calcitek, Inc.
Dental · 143d
Cleared Jun 28, 1990
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
K900809 · DYW
Lee Pharmaceuticals
Dental · 127d
Cleared Jun 28, 1990
IONOMETER EH
K901039 · CEM
Fresenius USA, Inc.
Chemistry · 114d
Cleared Jun 28, 1990
ENEMA BUCKET SET
K901179 · FCE
Orion Life Systems, Inc.
Gastroenterology & Urology · 107d