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
161257–161280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1982
DIALYSIS CONCENTRATE
K813586 · KPO
Diversified Medical Services
Gastroenterology & Urology · 32d
Cleared Jan 29, 1982
HOLTER PERFORMER
K813602 · DSH
Applied Cardiac Systems
Cardiovascular · 32d
Cleared Jan 29, 1982
CORONARY INFUSION KIT
K820001 · DQO
Mallinckrodt Critical Care
Cardiovascular · 25d
Cleared Jan 29, 1982
NEISSERIA GONORRHOEAE TEST
K820007 · LIC
New Horizons Diagnostics Co.
Microbiology · 25d
Cleared Jan 29, 1982
PIPERACILLIN 100MCG. ANTIMICROBIAL
K820019 · JTN
General Diagnostics
Microbiology · 24d
Cleared Jan 29, 1982
CARDIOVASCULAR DEVICES
K820045 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jan 29, 1982
ANESTHESIOLOGY DEVICES
K820046 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jan 29, 1982
OBUS FORME ORTHOPEDIC BRACE, UPRIGHT
K820051 · IQE
Obus Forme, Ltd.
Physical Medicine · 21d
Cleared Jan 29, 1982
ELASTIC BANDAGE
K820094 · FQM
Stan-Pak Ent.
General Hospital · 16d
Cleared Jan 29, 1982
SUBCLAVIAN JUGULAR CATHETER SET
K820102 · DQR
Luther Medical Products, Inc.
Cardiovascular · 14d
Cleared Jan 29, 1982
RADIATION STERILIZED SUCTION CATHETERS
K820109 · BSY
Travenol Laboratories, S.A.
Anesthesiology · 14d
Cleared Jan 29, 1982
PATIENT GUIDED KNEE EXERCISER
K820120 · BXB
Richard'S Medical Equip., Inc.
Physical Medicine · 11d
Cleared Jan 29, 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL
K820129 · LAS
Syva Co.
Toxicology · 11d
Cleared Jan 29, 1982
URINARY DRAINAGE BAG
K820136 · KNX
Megaplast, Inc.
Gastroenterology & Urology · 11d
Cleared Jan 29, 1982
K-AID
K820150 · KPO
Sytek Laboratories
Gastroenterology & Urology · 10d
Cleared Jan 29, 1982
KEY MED LEEDS ENDOSCOPE DISINFECTOR
K820152 · FEB
Keymed, Inc.
General Hospital · 10d
Cleared Jan 29, 1982
O.N.A.T.
K820175 · KNC
Latex Medical Devices, Inc.
Obstetrics & Gynecology · 8d
Cleared Jan 29, 1982
BIO-DERM COUPLING LOTION
K827885 · HGL
Whs Products, Inc.
Radiology · 28d
Cleared Jan 28, 1982
DATAPASS
K812435 · IYO
General Electric Co.
Radiology · 156d
Cleared Jan 28, 1982
PIPERACILLIN 100 MCG. SENSITIVITY DISCS
K812524 · JTN
Difco Laboratories, Inc.
Immunology · 148d
Cleared Jan 28, 1982
PILLING LACRIMAL INTUBATION SYSTEM
K813187 · HNL
Narco Scientific
Ophthalmic · 73d
Cleared Jan 28, 1982
SERACULT OCCULT BLOOF TEST
K813204 · KHE
Propper Mfg. Co., Inc.
Hematology · 76d
Cleared Jan 28, 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205 · DTB
Extracorporeal Medical Specialities,...
Cardiovascular · 76d
Cleared Jan 28, 1982
OXYGENAIRE NURING INCUBATOR
K813239 · FMZ
Vickers America Medical Corp.
General Hospital · 72d