FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126025–126048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 28, 1990
ENEMA BAG SET
K901182 · FCE
Orion Life Systems, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 28, 1990
LAMINECTOMY RONGEUR
K901372 · HAE
Zeppelin GmbH
Neurology · 98d
Cleared Jun 28, 1990
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
K901503 · ESE
Stanton Magnetics, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 28, 1990
MOUTHPIECE BREATHING
K901563 · JXL
Scott All-Sports, Inc.
Neurology · 86d
Cleared Jun 28, 1990
LATEX EXAMINATION GLOVES
K901579 · LYY
P.T. Perkebunan
General Hospital · 85d
Cleared Jun 28, 1990
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
K901584 · DWA
Bio Medicus, Inc.
Cardiovascular · 85d
Cleared Jun 28, 1990
ELECTROGLOTTOGRAPH
K901609 · KLX
Glottal Ent., Inc.
Ear, Nose, Throat · 83d
Cleared Jun 28, 1990
RUBELLA IGG ELISA TEST
K901635 · LFX
Gull Laboratories, Inc.
Microbiology · 80d
Cleared Jun 28, 1990
MODIFIED IVT PERIPHERAL ATHERECTOMY
K901767 · LIT
Intensive Technology, Inc.
Cardiovascular · 72d
Cleared Jun 28, 1990
LATEX PATIENT EXAMINATION GLOVES
K901801 · LYY
Fujian Provincial Medicines and...
General Hospital · 70d