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
132721–132744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1989
TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
K884788 · JAK
Toshiba Medical Systems
Radiology · 104d
Cleared Feb 27, 1989
BIOTENS
K884814 · GXY
Trekk Intl.
Neurology · 102d
Cleared Feb 27, 1989
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
K884889 · KWL
Protek, Inc.
Orthopedic · 97d
Cleared Feb 27, 1989
BALANCE SYSTEM
K884926 · LXV
Chattanooga Group, Inc.
Ear, Nose, Throat · 91d
Cleared Feb 27, 1989
INFUSA-PLATE(TM) EX
K885083 · FRN
Kalayjian Ent.
General Hospital · 80d
Cleared Feb 27, 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129 · JOH
Bivona Medical Technologies
Anesthesiology · 77d
Cleared Feb 27, 1989
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K885130 · JOH
Bivona Medical Technologies
Anesthesiology · 77d
Cleared Feb 27, 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · KNW
Boston Scientific Corp
Gastroenterology & Urology · 76d
Cleared Feb 27, 1989
ADVANTAGE
K885246 · GWF
Clark Davis Medical Systems, Inc.
Neurology · 67d
Cleared Feb 27, 1989
CALCIUM PLUS PROCEDURE
K890302 · CJY
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Feb 27, 1989
PROTECTOR (SURGICAL INSTRUMENT)
K890314 · MMK
Richard-Allan Medical Ind., Inc.
General Hospital · 35d
Cleared Feb 27, 1989
GLUCOSE (GOD) REAGENT
K890336 · CGA
Alpkem Corp.
Chemistry · 35d
Cleared Feb 27, 1989
LC, CARDIAC POSITIONER #B5078A
K890348 · IZI
General Electric Co.
Radiology · 35d
Cleared Feb 27, 1989
VAGINAL SPECULUM
K890376 · HFD
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
CERVICAL BIOPSY FORCEPS
K890380 · HFB
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
COMPRESSION FORCEPS
K890382 · HFW
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
MALLEABLE PLACENTA CURETTE
K890387 · HEX
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409 · GGP
Baxter Healthcare Corp
Hematology · 34d
Cleared Feb 27, 1989
PMS ANGIO DRAPE
K890471 · KKX
Professional Medical Services
General Hospital · 27d
Cleared Feb 27, 1989
RUG BUG WHEEL CHAIR
K890490 · ITI
Sinties Scientific, Inc.
Physical Medicine · 27d
Cleared Feb 27, 1989
MICROLITE TUBE LUMINOMETER #011-902-0000
K890502 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 26d
Cleared Feb 27, 1989
SURE COUNT LIGHT HANDLE COVER
K890539 · FTA
Kleen Test Products
General & Plastic Surgery · 24d
Cleared Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Feb 27, 1989
NIDEK AR-1200
K890559 · HKO
Nidek, Inc.
Ophthalmic · 21d