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
86113–86136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1999
SMARTCELL PROCESSING SYSTEM
K983022 · CAC
Harvest Technologies, LLC
Anesthesiology · 214d
Cleared Apr 02, 1999
TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
K983115 · JAQ
Nucletron Corp.
Radiology · 210d
Cleared Apr 02, 1999
ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
K983337 · JAQ
Nucletron Corp.
Radiology · 191d
Cleared Apr 02, 1999
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K983343 · MUJ
Nucletron Corp.
Radiology · 191d
Cleared Apr 02, 1999
THERAPEP
K983467 · BWF
Dhd Healthcare Corp.
Anesthesiology · 189d
Cleared Apr 02, 1999
STERICHEK TOTAL CHLORINE TEST KIT
K983997 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 143d
Cleared Apr 02, 1999
STERILE BACK SURGICAL GOWN WITH HAND TOWEL
K984422 · FYA
Medical Sterilization, Inc.
General Hospital · 113d
Cleared Apr 02, 1999
TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984513 · JTN
Oxoid , Ltd.
Microbiology · 105d
Cleared Apr 02, 1999
DCI ENDOSCOPE
K990004 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 02, 1999
MULTI-CURE COMPOSITE CEMENT
K990314 · EBF
Medental Intl.
Dental · 60d
Cleared Apr 02, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K990495 · LZA
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED NITRILE EXAMINATION GLOVES
K990499 · LZA
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
K990501 · LYY
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K990502 · LYY
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
HELIOFORM GOLD-BASED ALLOY
K990670 · EJT
C. Hafner GmbH & Co.
Dental · 31d
Cleared Apr 02, 1999
ENVY GUIDING CATHETER
K990726 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Apr 02, 1999
SOF-SUCTION FLUID EVACUATION SYSTEM
K990749 · HOZ
X-Tech Medical, LLC
Ophthalmic · 25d
Cleared Apr 02, 1999
VISION PORCELAIN
K990790 · EIH
Servo Dental USA, Inc.
Dental · 23d
Cleared Apr 01, 1999
INTERPLANT
K982696 · MUJ
Burdette Medical Systems, Inc.
Radiology · 241d
Cleared Apr 01, 1999
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
K983524 · GEX
Lares Research, Inc.
General & Plastic Surgery · 175d
Cleared Apr 01, 1999
POINT SETTER
K984355 · GCJ
Mitaka USA, Inc.
General & Plastic Surgery · 115d
Cleared Apr 01, 1999
QUICKRAY DSX 730
K990002 · MUH
Julie Alliance
Radiology · 87d
Cleared Apr 01, 1999
OPART, MODEL MRT-600
K990007 · MOS
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Apr 01, 1999
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K990028 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 86d