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
118369–118392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1992
SEQUENCE LIGHT CURE ADHESIVE
K914727 · DYH
Ormco Corp.
Dental · 88d
Cleared Jan 17, 1992
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K914735 · GWM
Camino Laboratories, Inc.
Neurology · 88d
Cleared Jan 17, 1992
LATEX EXAMINATION GLOVES
K914760 · LYY
Ansell, Inc.
General Hospital · 87d
Cleared Jan 17, 1992
STERN ERA IMPLANT ABUTMENT
K914764 · DZE
Sterngold/Implamed
Dental · 87d
Cleared Jan 17, 1992
SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES
K914766 · HQY
Sun Sight Glasses Co., Ltd.
Ophthalmic · 87d
Cleared Jan 17, 1992
HYPOALLERGENIC SURGEON'S GLOVES - STERILE
K914824 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 81d
Cleared Jan 17, 1992
IL TEST(TM) TRANSFERRIN (TRF)
K914993 · DDG
Instrumentation Laboratory CO
Immunology · 71d
Cleared Jan 17, 1992
DIFFERENTIAL COUNTING BOARD
K915071 · GKZ
Biovation, Inc.
Hematology · 70d
Cleared Jan 17, 1992
ESTISEAL LC
K915095 · EBC
Heraeus Kulzer, Inc.
Dental · 70d
Cleared Jan 17, 1992
TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915383 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915384 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER
K915397 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER
K915398 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
COMPLEMENT C1 INACTIVATOR KIT
K915431 · DBA
The Binding Site, Ltd.
Immunology · 46d
Cleared Jan 17, 1992
SPECT TABLE, MODEL #056-760
K915541 · IYZ
Atomic Products Corp.
Radiology · 38d
Cleared Jan 17, 1992
SRI DIGOXIN ENZYME IMMUNOASSAY
K915602 · KXT
Serono-Baker Diagnostics, Inc.
Toxicology · 35d
Cleared Jan 17, 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · HRS
Synthes (Usa)
Orthopedic · 18d
Cleared Jan 16, 1992
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · KTT
Howmedica Corp.
Orthopedic · 315d
Cleared Jan 16, 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · LZO
Biomet, Inc.
Orthopedic · 175d
Cleared Jan 16, 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · KWP
Zimmer, Inc.
Orthopedic · 160d
Cleared Jan 16, 1992
MODEL #05 ANEROID SPHYGMOMANOMETER KIT
K913814 · ELY
National Health-Care Equipment, Inc.
Dental · 143d
Cleared Jan 16, 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · KTT
Synthes (Usa)
Orthopedic · 93d
Cleared Jan 16, 1992
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
K914694 · JCX
Depuy, Inc.
General & Plastic Surgery · 90d
Cleared Jan 16, 1992
GLOBAL TOTAL SHOULDER
K914695 · KWT
Depuy, Inc.
Orthopedic · 90d