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
166417–166440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1980
NEBULIZER WITH AIR ENTERTAINER & ETC.
K801252 · BTT
Airlife, Inc.
Anesthesiology · 7d
Cleared Jun 04, 1980
PENLON JUMBO CARBON DIOXIDE ABSORBER
K801255 · BSF
Penlon, Inc.
Anesthesiology · 7d
Cleared Jun 04, 1980
NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY
K801256 · BXX
Kleen Test Products
Anesthesiology · 7d
Cleared Jun 04, 1980
NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.
K801257 · BXX
Kleen Test Products
Anesthesiology · 7d
Cleared Jun 04, 1980
NEEDLE COUNTER-SURE COUNT/10 COUNT
K801258 · BXX
Kleen Test Products
Anesthesiology · 7d
Cleared Jun 04, 1980
DISPOSABLE PRESSURE LINE ADAPTOR
K801260 · BYX
Intec Medical, Inc.
Anesthesiology · 7d
Cleared Jun 02, 1980
CAPIK-CANDIDA ALBICANS IDENT. KIT.
K800908 · JXB
Immuno-Mycologics, Inc.
Microbiology · 42d
Cleared Jun 02, 1980
TRYPTICASE SOY AGAR W5% SHEEP BLOOD
K800986 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 40d
Cleared Jun 02, 1980
MUELLER HINTON AGAR
K800987 · JTZ
Quality Assurance Laboratory, Inc.
Microbiology · 40d
Cleared Jun 02, 1980
DYNAWASHER II
K800989 · JTC
Dynatech Laboratories, Inc.
Microbiology · 39d
Cleared Jun 02, 1980
MULTI-AD FLUID DISPENSING PUMP MP-3000
K801008 · KYX
Burron Medical Products, Inc.
General Hospital · 35d
Cleared Jun 02, 1980
AMES GLUCOMETER REFLECT. PHOTOMETER
K801044 · JJQ
Miles Laboratories, Inc.
Chemistry · 28d
Cleared May 30, 1980
ALLER-SCREEN SKIN TEST KIT
K791328 · SCL
Aller-Screen, Inc.
General Hospital · 323d
Cleared May 30, 1980
LEAD, TINED PACING, IMPLANTABLE
K800354 · DTB
Daig Corp.
Cardiovascular · 105d
Cleared May 30, 1980
BARIUM SULFATE, USP IN SUSPENSION
K800459 · KTA
Central Pharmaceuticals, Inc.
Radiology · 91d
Cleared May 30, 1980
A-GENT QUANTICHROM THROMBIGEN-E
K800656 · GGQ
Abbott Laboratories
Hematology · 66d
Cleared May 30, 1980
REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
K800681 · KMS
Diagnostic Solutions, Inc.
Chemistry · 65d
Cleared May 30, 1980
REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-
K800689 · CKA
Diagnostic Solutions, Inc.
Chemistry · 65d
Cleared May 30, 1980
MMG DISPOSABLE URINARY LEG BAG
K800694 · KNX
Medical Marketing Group
Gastroenterology & Urology · 64d
Cleared May 30, 1980
FIBRINOGEN SCREEN
K800826 · KQJ
Pacific Hemostasis
Hematology · 46d
Cleared May 30, 1980
MEDESCAN
K800839 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
MEDEBAR M
K800841 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
MEDEBAR XAC-90
K800842 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
MEDEBAR XL
K800844 · KTA
Medefield Pty. , Ltd.
Radiology · 45d