Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
137089–137112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · CHI
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CRSC)
K875191 · JFY
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192 · JHY
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
K875248 · JMT
Bioscan Instruments, Inc.
Chemistry · 64d
Cleared Feb 24, 1988
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
K880029 · KFH
Immuno-Mycologics, Inc.
Microbiology · 50d
Cleared Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · JJX
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 24, 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · IPF
Chattanooga Group, Inc.
Physical Medicine · 35d
Cleared Feb 24, 1988
CARETEX SURGEON'S HOODS
K880431 · FXY
James River Corp.
General Hospital · 23d
Cleared Feb 24, 1988
CARETEX SURGEON'S CAPS
K880481 · FYF
James River Corp.
General & Plastic Surgery · 19d
Cleared Feb 24, 1988
CART, INSTRUMENT
K880536
Ferguson Medical
General & Plastic Surgery · 15d
Cleared Feb 24, 1988
CART, MULTIPURPOSE
K880539
Ferguson Medical
General & Plastic Surgery · 15d
Cleared Feb 24, 1988
LIGHT, SURGICAL, FLOOR STANDING
K880540 · FSS
Ferguson Medical
General & Plastic Surgery · 15d
Cleared Feb 24, 1988
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650 · GCY
Baxter Healthcare Corp
General & Plastic Surgery · 7d
Cleared Feb 23, 1988
RIONET HEARING AID HB-75
K874510 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 113d
Cleared Feb 23, 1988
IN-THE-EAR HEARING AID
K875010 · ESD
Statco Hearing Aid Laboratory
Ear, Nose, Throat · 81d
Cleared Feb 23, 1988
PERIODONTAL SCALING SOLUTION-A
K875132 · EFS
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
PERIDONTAL SCALING SOLUTION-B
K875149 · EFS
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
PERIODONTAL SCALING SOLUTION-C
K875150 · EFS
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
AMPLAID 309 CLINICAL AUDIOMETER
K880059 · EWO
Amplus Corp.
Ear, Nose, Throat · 47d
Cleared Feb 23, 1988
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
K880285 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 29d
Cleared Feb 23, 1988
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 29d
Cleared Feb 23, 1988
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Feb 23, 1988
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
K880466 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Feb 22, 1988
RHYTHMSCAN
K871572 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 306d