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
146905–146928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1985
RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR
K853083 · BYJ
Home Medical Supply, Inc.
Anesthesiology · 42d
Cleared Sep 03, 1985
PAX METER
K853085 · JAX
Peace Medical, Inc.
Anesthesiology · 42d
Cleared Sep 03, 1985
IMMUNO-IM
K853105 · KTN
Immunostics Co., Inc.
Immunology · 42d
Cleared Sep 03, 1985
DIMENSION TOTAL HIP PROSTHESIS
K853333 · KDI
Kirschner Medical Corp.
Gastroenterology & Urology · 26d
Cleared Sep 03, 1985
SERA-210 ELECTROLYTE ANALYZER
K853356 · CEM
Horiba Instruments, Inc.
Chemistry · 22d
Cleared Sep 03, 1985
N20 TEST
K853360 · CBR
Erich Jaeger, Inc.
Anesthesiology · 22d
Cleared Sep 03, 1985
H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
K853362 · JXG
Holter-Hausner Intl.
Neurology · 22d
Cleared Sep 03, 1985
H-H CRUCIFORM-SLIT VALVE
K853363 · JXG
Holter-Hausner Intl.
Neurology · 22d
Cleared Sep 03, 1985
PLATE INCUBATOR
K853379 · JTQ
Scientific Sales Intl., Inc.
Microbiology · 22d
Cleared Aug 30, 1985
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368 · JIN
Sigma Chemical Co.
Chemistry · 211d
Cleared Aug 30, 1985
COULTER VOLUME ADAPTER
K851943 · GKL
Coulter Electronics, Inc.
Hematology · 119d
Cleared Aug 30, 1985
CAT. NO. S-5300-E BIRTHING BED
K852171 · KNC
Shampaine/Wilson
Obstetrics & Gynecology · 102d
Cleared Aug 30, 1985
FETA SCAN 1000 OBSTETRICAL IMAGER
K852439 · HEM
International Biomedics, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 30, 1985
ATRAUM WOUND DRESSING
K852614 · FRO
Axiom Medical, Inc.
General & Plastic Surgery · 71d
Cleared Aug 30, 1985
FOR USE IN EAR
K852695 · EWG
Minnesota Laser Corp.
Ear, Nose, Throat · 65d
Cleared Aug 30, 1985
KENDALL CURITY BURN PAD
K853145 · FPY
The Kendal Co.
General & Plastic Surgery · 32d
Cleared Aug 30, 1985
I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI
K853242
U.S. Mfg. & Management, Inc.
General & Plastic Surgery · 29d
Cleared Aug 29, 1985
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
K844814 · DTD
Intermedics, Inc.
Cardiovascular · 261d
Cleared Aug 29, 1985
SYVA SOLID PHASE COLUMNS
K844948 · KEA
Syva Co.
Chemistry · 252d
Cleared Aug 29, 1985
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · DTD
Medtronic Vascular
Cardiovascular · 174d
Cleared Aug 29, 1985
DEFI 502
K851485 · LDD
Robert Bosch Corp.
Cardiovascular · 136d
Cleared Aug 29, 1985
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860
K851731 · DTB
Ela Medical, Inc.
Cardiovascular · 126d
Cleared Aug 29, 1985
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745 · ERA
Artiberia
Ear, Nose, Throat · 126d
Cleared Aug 29, 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · LDF
NuMED, Inc.
Cardiovascular · 125d