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
171721–171744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1978
COLD CYCLE, CHEMICAL COLD PACK
K780014 · IMD
Signal West
Physical Medicine · 49d
Cleared Feb 21, 1978
BLACK BAG, ELECTRONIC
K780023 · LDE
Marshall Electronics, Inc.
Cardiovascular · 48d
Cleared Feb 21, 1978
MATTRESSES, CONDUCTIVE & COVERS
K780033 · FMW
Chase Mfg. Co.
General Hospital · 43d
Cleared Feb 21, 1978
AUTOCLAVE POUCHES&ROLLS/STEAM&GAS
K780034 · FRG
E.M. Adams
General Hospital · 43d
Cleared Feb 21, 1978
URINE SAMPLE COLLECTION KIT
K780057 · FMH
C.R. Bard, Inc.
General Hospital · 42d
Cleared Feb 21, 1978
NEEDLE CONNECTING SET, BLUNT
K780105 · FOZ
Abbott Laboratories
General Hospital · 32d
Cleared Feb 21, 1978
PARENTERAL INFUSION CONTROLLER, ELEC.
K780106 · FLN
National Patent Development Corp.
General Hospital · 32d
Cleared Feb 21, 1978
CATHETERIZATION PROCEDURE TRAY
K780123 · FCM
Walpak Co.
Gastroenterology & Urology · 28d
Cleared Feb 21, 1978
CATHETERIZATION PROCED. TRAY, URETHRAL
K780124 · FCM
Walpak Co.
Gastroenterology & Urology · 28d
Cleared Feb 21, 1978
BURETTE INTRAVENOUS ADMIN. SETS.
K780130 · FPA
Y
General Hospital · 28d
Cleared Feb 21, 1978
STRESS TEST SYSTEM
K780166 · DPS
Quinton, Inc.
Cardiovascular · 20d
Cleared Feb 21, 1978
CATH KIT, URINE SPECIMEN
K780167 · FMH
C.R. Bard, Inc.
General Hospital · 19d
Cleared Feb 21, 1978
GLOVES, FLOOR
K780181 · FML
Tillotson Rubber Co., Inc.
General Hospital · 18d
Cleared Feb 21, 1978
CATHETER STRAP & RUINARY BAY HOLDER
K780190 · FAQ
Baka Manufacturing Co., Inc.
Gastroenterology & Urology · 15d
Cleared Feb 21, 1978
HEARING AID, BODY WORN
K780197 · ESD
Oticon Corp.
Ear, Nose, Throat · 15d
Cleared Feb 21, 1978
MONOMER EVACUATION SYSTEM
K780202 · JDY
Medishield, Inc.
Orthopedic · 14d
Cleared Feb 21, 1978
GENERATOR, ELECTROSURGICAL
K780206 · GEI
Valleylab, Inc.
Radiology · 14d
Cleared Feb 21, 1978
BANDAGE, ELASTIC
K780231 · FQM
Biomet, Inc.
General Hospital · 12d
Cleared Feb 21, 1978
RESTRAINT, PROTECTIVE
K780232 · FMQ
Biomet, Inc.
General Hospital · 12d
Cleared Feb 17, 1978
EK-670
K780138 · DPS
Burdick Corp.
Cardiovascular · 23d
Cleared Feb 17, 1978
HANDPIECE, LIFT, ENDO
K780213 · EGS
Kerr Corporation (Danbury)
Dental · 9d
Cleared Feb 17, 1978
SPREADER BARS
K780226 · ILZ
Biomet, Inc.
Physical Medicine · 8d
Cleared Feb 17, 1978
COMPRESSION MULTISONIC
K780241 · ESD
Qualitone
Ear, Nose, Throat · 4d
Cleared Feb 16, 1978
PROPHY CUPS, R&R
K780198 · EHK
Ransom and Randolph
Dental · 9d