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
132505–132528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1989
MONO-CUBE(TM)
K890991 · KTN
Difco Laboratories, Inc.
Immunology · 17d
Cleared Mar 16, 1989
LATEX EXAMINATION GLOVES
K891065 · LYY
Modern Rubber Industrial Co., Ltd.
General Hospital · 15d
Cleared Mar 16, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
K891154 · MSJ
Atlantic Antibodies
Immunology · 10d
Cleared Mar 16, 1989
DEFEND LATEX EXAMINATION GLOVES
K891157 · LYY
Carl Parker Associates, Inc.
General Hospital · 10d
Cleared Mar 15, 1989
PG-NUMERIC(TM)
K883411 · JHF
Isolab, Inc.
Chemistry · 212d
Cleared Mar 15, 1989
LYME DISEASE IFA (IGM)
K883767 · LSR
Hillcrest Biologicals
Microbiology · 190d
Cleared Mar 15, 1989
MULTI CAMERA CONTROL UNIT (MCCU)
K884028 · JAA
Leybold-Inficon, Inc.
Radiology · 173d
Cleared Mar 15, 1989
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B
K884477 · KPR
Shimadzu Precision Instruments, Inc.
Radiology · 141d
Cleared Mar 15, 1989
VAPAMASTA 5
K884686 · CAD
Dentsply Intl.
Anesthesiology · 127d
Cleared Mar 15, 1989
B.A.C. 1000 MOBILE STANDING DEVICE
K884840 · IPL
Luconex, Inc.
Physical Medicine · 114d
Cleared Mar 15, 1989
ASTRO TRACE (MODEL AT-02)
K885137 · DSA
The LE Blanc Corp.
Cardiovascular · 90d
Cleared Mar 15, 1989
TOTAL KNEE CPM
K885182 · BXB
Invacare Corp.
Physical Medicine · 91d
Cleared Mar 15, 1989
ARROW MICRO COMPUTER CONTROL
K885212 · ITI
Invacare Corp.
Physical Medicine · 86d
Cleared Mar 15, 1989
ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS
K885261 · ITI
Invacare Corp.
Physical Medicine · 83d
Cleared Mar 15, 1989
VISUWELL REAGIN TEST 960 TEST KIT
K885298 · GMP
Allelix Diagnostics, Inc.
Microbiology · 78d
Cleared Mar 15, 1989
AML BOWED FEMORAL HIP
K885338 · JDI
Depuy, Inc.
Orthopedic · 77d
Cleared Mar 15, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K890060 · LZO
Depuy, Inc.
Orthopedic · 65d
Cleared Mar 15, 1989
MICROLASE 8 0 0 (OPHTHALMIC LASER)
K890086 · HQF
Keeler Instruments, Inc.
Ophthalmic · 64d
Cleared Mar 15, 1989
ENGSTROM ELIZA + CO2 ANALYZER
K890112 · CCK
Gambro, Inc.
Anesthesiology · 63d
Cleared Mar 15, 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · DRX
Medtronic Vascular
Cardiovascular · 57d
Cleared Mar 15, 1989
HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
K890281 · LSR
Cambridge Bioscience Corp.
Microbiology · 57d
Cleared Mar 15, 1989
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · LIT
C.R. Bard, Inc.
Cardiovascular · 51d
Cleared Mar 15, 1989
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
K890414 · JJY
Amersham Corp.
Chemistry · 50d
Cleared Mar 15, 1989
RIATRAC PLUS
K890470 · JJY
Bd Becton Dickinson Vacutainer...
Chemistry · 43d