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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171505–171528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1978
ELECATH PLASTIC JACKETED GUIDEWIRE
K780493 · DQX
Electro-Catheter Corp.
Cardiovascular · 14d
Cleared Apr 10, 1978
AMIKACIN
K780494 · KLQ
Diagnostic Products Corp.
Toxicology · 14d
Cleared Apr 10, 1978
DIGITOXIN
K780495 · DJK
Diagnostic Products Corp.
Toxicology · 14d
Cleared Apr 10, 1978
NOVA AIR FLOATATION SYSTEM
K780502 · FNM
Nova Health Systems, Inc.
General Hospital · 12d
Cleared Apr 10, 1978
INFUSION PUMP
K780503 · FRN
Air-Shields, Inc.
General Hospital · 12d
Cleared Apr 10, 1978
BEHIND-THE-EAR MASKING AMPLIFIER,735S
K780546 · KLW
Danavox, Inc.
Ear, Nose, Throat · 5d
Cleared Apr 10, 1978
STERILE ORTHOPEDIC STOCKINETTE
K780547 · ILG
Alba-Waldensian, Inc.
Physical Medicine · 5d
Cleared Apr 07, 1978
SOLID-OX EMERGENCY OXYGEN
K780366 · CAW
Cleanweld Products, Inc.
Anesthesiology · 32d
Cleared Apr 06, 1978
NEPHELOMETER
K780251 · JQX
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Apr 06, 1978
CHOLESTEROL RAPID SLAT KIT HDL
K780331 · CHH
Pierce Chemical Co.
Chemistry · 37d
Cleared Apr 05, 1978
LEAD HAND
K772387 · KKX
Edward Weck, Inc.
General Hospital · 99d
Cleared Apr 05, 1978
ATOMIZER, FURNACE, GRAPHITE
K780129 · JXR
The Perkin-Elmer Corp.
Toxicology · 71d
Cleared Apr 05, 1978
DIRECT UREA NITROGEN TEST
K780262 · CDW
Hycel, Inc.
Chemistry · 47d
Cleared Apr 05, 1978
CALIBRATORS, CARBON DIOXIDE
K780295 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Apr 05, 1978
DIAGNOSTIC KIT, CPK
K780311 · CGS
Sclavo, Inc.
Chemistry · 40d
Cleared Apr 05, 1978
AUTONOM
K780312 · KNM
Autonomic Equipment Supply Co,
Physical Medicine · 49d
Cleared Apr 05, 1978
DRI-LYTE
K780353 · KPO
Mallinckrodt Critical Care
Gastroenterology & Urology · 33d
Cleared Apr 05, 1978
TITANIUM MULLER TOTAL HIP
K780357 · JDG
Biomet, Inc.
Orthopedic · 30d
Cleared Apr 05, 1978
INFANT ELECTROSURGICAL GROUNDING PAD
K780405 · JOS
New Dimensions IN Medicine, Inc.
General & Plastic Surgery · 23d
Cleared Apr 05, 1978
PACEMAKER, MODEL 252, C-MOS
K780437 · DXY
Intermedics, Inc.
Cardiovascular · 16d
Cleared Apr 05, 1978
PREBYPASS FILTER
K780485 · KRJ
Delta Medical Industries
Cardiovascular · 9d
Cleared Apr 05, 1978
CBR-DIGOXIN ANTISERUM
K780498 · DKA
Clinical Bioresearch
Toxicology · 8d
Cleared Apr 04, 1978
PREGNANCY TEST KIT, OVER-THE-COUNTER
K780321 · LCX
Intl. Diagnostic, Inc.
Chemistry · 39d
Cleared Apr 04, 1978
OXYGEN REGULATOR/FLOWMETER
K780359 · CAN
Erie Mfg., Co.
Anesthesiology · 29d