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
170209–170232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1978
OVALITH 10BP
K781377 · DXY
Coratomic, Inc.
Cardiovascular · 117d
Cleared Dec 04, 1978
ENDOCARDIAL BIPOLAR LEAD
K781456 · DTB
American Technology, Inc.
Cardiovascular · 103d
Cleared Dec 04, 1978
DIRECT ESTRIOL RIA KIT
K781546 · CGI
Immunalysis Corporation
Chemistry · 82d
Cleared Dec 04, 1978
DISPOSABLE LYMPHANGIOGRAM SET
K781575 · FPA
Instranetics, Inc.
Radiology · 81d
Cleared Dec 04, 1978
SURGICAL ASPIRATOR TIPS
K781592 · DYN
Henry Schein, Inc.
Dental · 77d
Cleared Dec 04, 1978
DENTAL WARM WATER IRRIGATING SYSTEM
K781594 · ECB
Rama Corp.
Dental · 80d
Cleared Dec 04, 1978
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · EAP
General Electric Co.
Radiology · 70d
Cleared Dec 04, 1978
X-RAY COLLIMATOR
K781675 · EHB
General X-Ray, Inc.
Radiology · 66d
Cleared Dec 04, 1978
AUROFIL
K781687 · EBF
Wallace A. Erickson & Co.
Dental · 62d
Cleared Dec 04, 1978
PEN, MARK-3 SKIN MARKING FOUNTAIN
K781694 · FZZ
Omega Mark-3 Pen Corp.
General & Plastic Surgery · 55d
Cleared Dec 04, 1978
BLOOD PRESSURE, DIGITAL MODEL #2153
K781701 · DSK
Sears, Roebuck & Co.
Cardiovascular · 55d
Cleared Dec 04, 1978
RULER, WECK SCOTT
K781715 · HOE
Edward Weck, Inc.
Ophthalmic · 60d
Cleared Dec 04, 1978
CHANGE IN STERILIZATION PROCEDURE
K781727 · GOY
Absorbent Cotton Co., Inc.
Chemistry · 54d
Cleared Dec 04, 1978
INHAMATIC 33
K781742 · IZD
Medimatic
Radiology · 48d
Cleared Dec 04, 1978
TUBING, AXIOM SILICONE PENROSE
K781749 · KDH
Axiom Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 04, 1978
SERACON-SRI
K781757 · JIX
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
SERACON-SRII
K781758 · JIX
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
PAD, COOLING #27-999
K781764 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 49d
Cleared Dec 04, 1978
IRON 59 KIT
K781769 · JJA
Ria Products, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
BLOOD SUGAR
K781783 · LFR
Gilford Diagnostics
Chemistry · 46d
Cleared Dec 04, 1978
OVU-GUIDE
K781817 · FLK
Reproduction Research Laboratories
General Hospital · 35d
Cleared Dec 04, 1978
COMPUTER, 3500, GILFORD SYSTEM
K781828 · KLI
Syva Co.
Chemistry · 35d
Cleared Dec 04, 1978
TELEMETRY SYSTEM, BIOTEL 300
K781836 · DRG
Spacelabs, Inc.
Cardiovascular · 35d
Cleared Dec 04, 1978
ELECTRODES, IMPLANTABLE WITH ADAPTER
K781849 · DTB
Telectronics, Inc.
Cardiovascular · 38d