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
137233–137256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1987
HVA & HOMOVANILLIC ACID BY HPLC METHOD
K873372 · CDF
Bio-Rad
Chemistry · 120d
Cleared Dec 22, 1987
ECMO-TEMP (TM) BLOOD WARMING DEVICE
K873699 · DWC
Seabrook Medical Systems, Inc.
Cardiovascular · 97d
Cleared Dec 22, 1987
TILSON TRACH GUARD
K873974 · BZA
Beevers Mfg. & Supply, Inc.
Anesthesiology · 84d
Cleared Dec 22, 1987
OPHTHALMIC DISPOSABLE BLADES
K874056 · HNN
Myocure, Inc.
Ophthalmic · 78d
Cleared Dec 22, 1987
INORGANIC PHOSPHORUS
K874472 · CEO
Catachem, Inc.
Chemistry · 50d
Cleared Dec 22, 1987
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
K874625 · DLZ
Syva Co.
Toxicology · 42d
Cleared Dec 22, 1987
WAKO(TM) AUTOKIT LIPASE
K874640 · CHI
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K874705 · JEJ
Em Diagnostic Systems, Inc.
Chemistry · 33d
Cleared Dec 22, 1987
MODIFIED PALLADIUM SEED MODEL 100
K874787 · IWI
Theragenics Corp.
Radiology · 29d
Cleared Dec 21, 1987
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628 · LSL
Ortho Diagnostic Systems, Inc.
Microbiology · 168d
Cleared Dec 21, 1987
CALIBRATION GAS FOR CARBON DIOXIDE MONITOR
K874297 · BXK
Liquid Air Corp.
Anesthesiology · 62d
Cleared Dec 21, 1987
RESPIRGARD II NEBULIZER SYSTEM
K874395 · CAF
Marquest Medical Products, Inc.
Anesthesiology · 54d
Cleared Dec 21, 1987
BABYFLEX PATIENT CIRCUIT
K874559 · BZO
Airoflex Medical, Inc.
Anesthesiology · 47d
Cleared Dec 21, 1987
SEALFLEX MASK
K874746 · BSJ
Engineered Medical Systems
Anesthesiology · 33d
Cleared Dec 18, 1987
MEC-I-TRON, MODEL P-1
K873190 · GZJ
Meyer Equipment Company, Inc.
Neurology · 127d
Cleared Dec 18, 1987
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771 · GYK
American V. Mueller
Neurology · 93d
Cleared Dec 18, 1987
NDNA ANTIBODY TEST KIT
K874191 · LRM
Lipogen, Inc.
Immunology · 65d
Cleared Dec 18, 1987
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · DHB
Medix Biotech, Inc.
Immunology · 59d
Cleared Dec 18, 1987
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
K874339 · DSK
A&D Engineering, Inc.
Cardiovascular · 58d
Cleared Dec 18, 1987
PCI MODEL RS100 TELEMETRY MONITOR
K874387 · DXH
Accucore, Inc.
Cardiovascular · 53d
Cleared Dec 18, 1987
MWI 400 WOUND DRESSING
K874470 · NAD
Med-West, Inc.
General & Plastic Surgery · 46d
Cleared Dec 18, 1987
IMACK-MB TEST PROCEDURE (MODIFICATION)
K874545 · JHY
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 18, 1987
KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED
K874547 · JWH
Kirschner Medical Corp.
Orthopedic · 45d
Cleared Dec 18, 1987
ENVISAN PASTE
K874553 · KOZ
Marion Laboratories, Inc.
General & Plastic Surgery · 44d