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
161113–161136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1982
PODIOSCOPE BY ARROW
K827069
Arrow X-Ray Corp.
Radiology · 31d
Cleared Feb 15, 1982
TRACE ANALYTICAL REDUCTION GAS ANALYZ
K820025 · KZQ
Trace Analytical
Toxicology · 41d
Cleared Feb 12, 1982
ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER
K813170 · GAG
Surgeons Choice, Inc.
General & Plastic Surgery · 87d
Cleared Feb 12, 1982
MEDICAL MULTILITH PULSE GENERA-1140
K813246 · DXY
Ela Medical, Inc.
Cardiovascular · 86d
Cleared Feb 12, 1982
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
K813350 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 77d
Cleared Feb 12, 1982
FETASCAN 2000,2000A OBSTETRICAL DATA
K813457 · HGM
Cranbury Medical Labs, Inc.
Obstetrics & Gynecology · 64d
Cleared Feb 12, 1982
SIL-V-UR CHEST CATHETER
K813463 · GBS
C.R. Bard, Inc.
General & Plastic Surgery · 63d
Cleared Feb 12, 1982
CURITY BEDSIDE DRAINAGE BAG
K813621 · KNX
The Kendal Co.
Gastroenterology & Urology · 45d
Cleared Feb 12, 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 32d
Cleared Feb 12, 1982
GLYCO-SEP REAGENT TEST SET
K820076 · LCP
Clin Tech Diagnostics Corp.
Hematology · 31d
Cleared Feb 12, 1982
X-RAY GUAZE SPONGES
K820106 · EFQ
Stan-Pak Ent.
General & Plastic Surgery · 28d
Cleared Feb 12, 1982
GUAZE SPONGES, PLAIN
K820107 · EFQ
Stan-Pak Ent.
General & Plastic Surgery · 28d
Cleared Feb 12, 1982
TOPPER SPONGES
K820108 · NAB
Stan-Pak Ent.
General & Plastic Surgery · 28d
Cleared Feb 12, 1982
BIOX III
K820110 · DQA
Biox Technology, Inc.
Anesthesiology · 28d
Cleared Feb 12, 1982
SYSTEM V.HEART RATE/RESPIR. RATE MONIT.
K820114 · DRT
Narco Air-Shields
Cardiovascular · 28d
Cleared Feb 12, 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · DTB
Telectronics, Inc.
Cardiovascular · 25d
Cleared Feb 12, 1982
WEBRIL CAST PADDING
K820140 · ITG
Stan-Pak Ent.
Physical Medicine · 24d
Cleared Feb 12, 1982
SPECIALIST CAST PADDING
K820155 · ITG
Stan-Pak Ent.
Physical Medicine · 24d
Cleared Feb 12, 1982
BARD CARDIOPULMONARY MONITORING LINES
K820186 · DRS
C.R. Bard, Inc.
Cardiovascular · 21d
Cleared Feb 12, 1982
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
K820187 · LES
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
CARBAMAZEPINE ASSAY
K820189 · KLT
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
CALIBRATOR SET
K820190 · DKB
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
CONTROL SET
K820191 · DIF
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
ELECTROSURGICAL DISP. DISPERSIVE PAD
K820196 · KNS
Promedicon, Inc.
Gastroenterology & Urology · 18d