FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71713–71736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2003
YA MEI FIRST AID KIT
K031130 · KGO
Ya Mei Technology Co., Ltd.
General Hospital · 79d
Cleared Jun 27, 2003
ORTHOMEND
K031188 · FTL
Tei Biosciences, Inc.
General & Plastic Surgery · 73d
Cleared Jun 27, 2003
SUSTAIN SPACER
K031302 · MQP
Globus Medical, Inc.
Orthopedic · 64d
Cleared Jun 27, 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · MNH
Ebi, L.P.
Orthopedic · 52d
Cleared Jun 27, 2003
BLASTFREEZE AND BLASTTHAW
K031486 · MQL
Medicult A/S
Obstetrics & Gynecology · 46d
Cleared Jun 27, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
K031538 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · MNH
U&I Corp., America
Orthopedic · 37d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · MNI
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared Jun 26, 2003
SMART BAG MO
K021328 · BTM
O-Two Systems International, Inc.
Anesthesiology · 426d
Cleared Jun 26, 2003
OSMONICS SOLUTION DELIVERY SYSTEM
K023011 · FIN
Osmonics Medical Systems
Gastroenterology & Urology · 290d
Cleared Jun 26, 2003
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON...
K024000 · DQO
Angiometrx, Inc.
Cardiovascular · 204d
Cleared Jun 26, 2003
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
K024181 · IPF
Prizm Medical, Inc.
Physical Medicine · 189d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · MNH
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995 · HWC
Mitek Worldwide
Orthopedic · 87d
Cleared Jun 26, 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 86d
Cleared Jun 26, 2003
TS3 TUBING SET
K031151 · DWF
Global Blood Resources, LLC
Cardiovascular · 77d
Cleared Jun 26, 2003
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE...
K031414 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 52d
Cleared Jun 26, 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND...
K031591 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 36d
Cleared Jun 26, 2003
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
K031622 · MQE
Portex , Ltd.
Obstetrics & Gynecology · 34d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cook, Inc.
Cardiovascular · 17d