Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
167257–167280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1980
SAMPLING MANIFOLD H530
K801200 · DTL
C.R. Bard, Inc.
Cardiovascular · 16d
Cleared Jun 04, 1980
ABCO PEDIATRIC STETHOSCOPE
K801215 · LDE
Abco Dealers, Inc.
Cardiovascular · 15d
Cleared Jun 04, 1980
BONDALCAP (SILICO-PHOSPHATE)
K801228 · EMA
Vivadent (Usa), Inc.
Dental · 12d
Cleared Jun 04, 1980
BONDALCAP (CARBOXYLATE)
K801229 · EMA
Vivadent (Usa), Inc.
Dental · 12d
Cleared Jun 04, 1980
BUILT-IN TEMPERATURE MONITORING
K801240 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 8d
Cleared Jun 04, 1980
NON-CONDUCTIVE, SINGLE USE FACE MASK #55
K801251 · BSJ
Vital Signs, Inc.
Anesthesiology · 7d
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