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

Filters: Cleared only ×
175,820 results
106321–106344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1994
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 169d
Cleared Dec 02, 1994
MODEL #700TO3500 NECK/ABDOMINAL COIL
K942873 · LNH
Medic, Inc.
Radiology · 168d
Cleared Dec 02, 1994
MODEL #900TO3500 HEAD/NECK COIL
K942875 · LNH
Medic, Inc.
Radiology · 168d
Cleared Dec 02, 1994
BILIRUBIN(TOTAL) QVET
K942999 · CIG
Prisma Systems
Chemistry · 162d
Cleared Dec 02, 1994
URIC ACID QVET
K943002 · KNK
Prisma Systems
Chemistry · 162d
Cleared Dec 02, 1994
IRON QVET
K943029 · JIY
Prisma Systems
Chemistry · 158d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291 · LLL
Sigma Diagnostics, Inc.
Immunology · 147d
Cleared Dec 02, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K943510 · JWY
Baxter Diagnostics, Inc.
Microbiology · 135d
Cleared Dec 02, 1994
MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS
K943543 · GEX
Medical Options, Inc.
General & Plastic Surgery · 133d
Cleared Dec 02, 1994
POINT OF USE SHARPS A GATOR
K943892 · FMI
Devon Industries, Inc.
General Hospital · 115d
Cleared Dec 02, 1994
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · DJR
Beckman Instruments, Inc.
Toxicology · 150d
Cleared Dec 02, 1994
PHLEBOTOMY UNIT SHARPS A GATOR
K944114 · FMI
Devon Industries, Inc.
General Hospital · 101d
Cleared Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · DIO
Roche Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Dec 02, 1994
COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER
K944303 · GCJ
Cook Urological, Inc.
General & Plastic Surgery · 91d
Cleared Dec 02, 1994
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
K944452 · JJY
Beckman Instruments, Inc.
Chemistry · 81d
Cleared Dec 02, 1994
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E
K944486 · JJY
International Enzymes, Inc.
Immunology · 80d
Cleared Dec 02, 1994
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E
K944513 · JJY
International Enzymes, Inc.
Immunology · 78d
Cleared Dec 02, 1994
PRIMA, INC. CORRUGATED TUBING
K944531 · BZO
Prima, Inc.
Anesthesiology · 78d
Cleared Dec 02, 1994
PRIMA, INC. VENTILATOR HOSES
K944532 · BZA
Prima, Inc.
Anesthesiology · 78d
Cleared Dec 02, 1994
CUTINOVA THIN WOUND DRESSING
K944581 · KMF
Beiersdorf, Inc.
General & Plastic Surgery · 74d
Cleared Dec 02, 1994
PROCERA ALL-CERAMIC PORCELAIN
K944702 · EIH
Nobelpharma USA, Inc.
Dental · 71d
Cleared Dec 02, 1994
OREX MEDICAL BEDDING
K944953 · KME
Thantex Specialties, Inc.
General Hospital · 56d
Cleared Dec 02, 1994
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · EBG
3M Company
Dental · 56d
Cleared Dec 02, 1994
THE SHARPS COLLECTION AND DISPOSAL SYSTEM
K945197 · MMK
Devon Industries, Inc.
General Hospital · 39d