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
134449–134472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1988
NOVA LITE(TM) SA
K881341 · LLL
Inova Diagnostics, Inc.
Immunology · 177d
Cleared Sep 22, 1988
GARDS DEODORANT SANITARY NAPKIN
K882094 · HHL
Hospital Specialty Co.
Obstetrics & Gynecology · 126d
Cleared Sep 22, 1988
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
K882231 · IYE
Philips Medical Systems, Inc.
Radiology · 118d
Cleared Sep 22, 1988
SPINAL MICROKNIFE
K882525 · HTS
Karlin Technology, Inc.
Orthopedic · 97d
Cleared Sep 22, 1988
EMPI MODEL 727,NMS
K882631 · GZJ
Empi
Neurology · 87d
Cleared Sep 22, 1988
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
K882678 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Sep 22, 1988
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
K882740 · LKJ
Lipogen, Inc.
Immunology · 83d
Cleared Sep 22, 1988
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · JLW
Amersham Corp.
Chemistry · 72d
Cleared Sep 22, 1988
TECHMEDICA MP SYSTEM
K882922 · KTT
Techmedica, Inc.
Orthopedic · 71d
Cleared Sep 22, 1988
QM300 CALIBRATOR D PACK
K883001 · CZJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Sep 22, 1988
QM300 PREALBUMIN ANTIBODY PACK
K883002 · JZJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Sep 22, 1988
EPICARDIA PC/FC
K883103 · DSI
Medicomp, Inc.
Cardiovascular · 62d
Cleared Sep 22, 1988
HIP FRACTURE STEM SYSTEM
K883179 · KWL
Howmedica Corp.
Orthopedic · 57d
Cleared Sep 22, 1988
AVL MODEL 986 ELECTROLYTE ANALYZER
K883240 · CEM
Avl Scientific Corp.
Chemistry · 52d
Cleared Sep 22, 1988
PARKER BATHING SYSTEM
K883308 · ILJ
Mid-Canada Medical
Physical Medicine · 48d
Cleared Sep 22, 1988
QUIDEL PREGNANCY TEST CONTROL
K883316 · JJX
Quidel Corp.
Chemistry · 48d
Cleared Sep 22, 1988
VISTA MR 2055 HP SYSTEM
K883378 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 44d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492 · CZP
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN M
K883493 · DFL
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 22, 1988
HERA H
K883508 · EJT
Degussa Dental, Inc.
Dental · 36d
Cleared Sep 22, 1988
HERAEUS DG 63
K883509 · EJS
Degussa Dental, Inc.
Dental · 36d
Cleared Sep 22, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · DCN
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 36d
Cleared Sep 22, 1988
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
K883518 · GWM
Metatech Corp.
Neurology · 37d
Cleared Sep 22, 1988
COMPEED ATHLETIC DRESSING
K883588 · FRO
Coloplast A/S
General & Plastic Surgery · 31d