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

118225–118248 of 174,955

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Jan 31, 1992

SPECIAL PURPOSE COILS FOR GYREX V

Radiology · 49d

Cleared Jan 31, 1992

CURITY VENTED DRESSING SYSTEM

Kendall Healthcare Products Co....

General & Plastic Surgery · 45d

Cleared Jan 31, 1992

MODEL H170 PEDIATRIC CHEST X-RAY UNIT

Radiology · 44d

Cleared Jan 30, 1992

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL

Enzyme Technology, Inc.

Chemistry · 267d

Cleared Jan 30, 1992

LOW BACK STRIP (OR) K-BACK

Neurology · 246d

Cleared Jan 30, 1992

NAUDE URETHRAL STENT

Cook Urological, Inc.

Gastroenterology & Urology · 216d

Cleared Jan 30, 1992

THRESHOLD 2X INSPIRATORY MUSCLE TRAINER

Health Products, Inc.

Anesthesiology · 209d

Cleared Jan 30, 1992

Neurology · 205d

Cleared Jan 30, 1992

DWYER EYE SYSTEMS ASPIRATION UNIT

Spectracare, Inc.

Ophthalmic · 191d

Cleared Jan 30, 1992

THE STERN ERA SYSTEM

Sterngold/Implamed

Ear, Nose, Throat · 188d

Cleared Jan 30, 1992

OXYGEN TUBING, 81503

Specialty Packaging Producs, Inc.

Anesthesiology · 183d

Cleared Jan 30, 1992

LIFECARE REMOTE ALARM II

Lifecare Services, Inc.

Anesthesiology · 192d

Cleared Jan 30, 1992

BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION

Bivona Medical Technologies

Anesthesiology · 156d

Cleared Jan 30, 1992

DANTEC COUNTERPOINT MK2(TM)

Dantec Medical, Inc.

Neurology · 148d

Cleared Jan 30, 1992

CHOLESTEROL REGEANT SET

Chemistry · 135d

Cleared Jan 30, 1992

E.R.C.P. CATHETER

Surgitek Medical Engineering Corp.

Gastroenterology & Urology · 114d

Cleared Jan 30, 1992

Moberg Medical, Inc.

Neurology · 107d

Cleared Jan 30, 1992

BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST

Beckman Instruments, Inc.

Chemistry · 92d

Cleared Jan 30, 1992

PROSPECT(TM) GIARDIA RAPID ASSAY

Microbiology · 79d

Cleared Jan 30, 1992

Psi Medical Products, Inc.

Gastroenterology & Urology · 57d

Cleared Jan 30, 1992

FIBRINOGEN FDP CONTROL

Cala Diagnostics

Hematology · 52d

Cleared Jan 30, 1992

Life Support Products, Inc.

Anesthesiology · 49d

Cleared Jan 30, 1992

CHOLEDOCHOSCOPE

Applied Laparoscopy

Gastroenterology & Urology · 42d

Cleared Jan 30, 1992

AMYLASE (COLORIMETRIC) REAGENT SET

Chemistry · 62d