FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90577–90600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1998
DAUM NEUROPUNCTURE NEEDLE
K974574 · KNW
Daum Corp.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1998
DAUM ASPIRATIONBIOPSY NEEDLE
K974575 · KNW
Daum Corp.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1998
DAUM BIOPSYGUN
K974576 · KNW
Daum Corp.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1998
IF-727 INTERFERENTIAL STIMULATOR
K974585 · LIH
Skylark Device Co., Ltd.
Neurology · 88d
Cleared Mar 06, 1998
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K974751 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 77d
Cleared Mar 06, 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889 · DHR
Diamedix Corp.
Immunology · 66d
Cleared Mar 06, 1998
CARESIDE ANALYZER
K980056 · JJF
Exigent Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 06, 1998
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K980190 · MOI
Chiron Corp.
Immunology · 45d
Cleared Mar 06, 1998
OSTEOMARK
K980518 · JMM
Ostex Intl., Inc.
Chemistry · 49d
Cleared Mar 06, 1998
AIMSTEP PREGNANCY
K980531 · JHI
Germaine Laboratories, Inc.
Chemistry · 23d
Cleared Mar 05, 1998
ESOP S/C FEMORAL STEM
K964878 · MEH
Fournitures Hospitalieres
Orthopedic · 455d
Cleared Mar 05, 1998
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
K972185 · FRO
Steripak, Ltd.
General & Plastic Surgery · 268d
Cleared Mar 05, 1998
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS...
K973836 · MNH
Cross Medical Products, Inc.
Orthopedic · 148d
Cleared Mar 05, 1998
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
K973883 · GWQ
Bio-Logic Systems Corp.
Neurology · 142d
Cleared Mar 05, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974291 · HTY
Mitek Products
Orthopedic · 111d
Cleared Mar 05, 1998
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
K974354 · MDA
Sca Molnlycke
General & Plastic Surgery · 106d
Cleared Mar 05, 1998
KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS
K974757 · KWQ
Acromed Corp.
Orthopedic · 76d
Cleared Mar 05, 1998
PSI-TEC ASPIRATOR
K980392 · BTA
Byron Medical
General & Plastic Surgery · 31d
Cleared Mar 04, 1998
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
K971840 · MHX
Invivo Research, Inc.
Cardiovascular · 289d
Cleared Mar 04, 1998
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE...
K972591 · JKM
Morax
Immunology · 236d
Cleared Mar 04, 1998
HANDI OXYGEN ANALYZER
K973282 · CCL
Ceramatec, Inc.
Anesthesiology · 183d
Cleared Mar 04, 1998
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K973802 · IYO
Shimadzu Medical Systems
Radiology · 149d
Cleared Mar 04, 1998
BIOSENSOR HOLTER MONITOR SYSTEM
K974192 · DQK
Biosensor Corp.
Cardiovascular · 117d
Cleared Mar 04, 1998
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
K974311 · KHJ
Gyrus Ent LLC
Ear, Nose, Throat · 107d