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
92305–92328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1997
2 BOND 2
K971733 · KLE
Heraeus Kulzer, Inc.
Dental · 146d
Cleared Oct 02, 1997
PULPDENT OX-OUT
K972445 · EMA
Pulpdent Corp.
Dental · 94d
Cleared Oct 02, 1997
SENSOR AMPLIFIER
K972515 · GWL
Pro-Tech Services, Inc.
Neurology · 91d
Cleared Oct 02, 1997
THUMPER
K972525 · DRM
Michigan Instruments, Inc.
Cardiovascular · 87d
Cleared Oct 02, 1997
BIO TROL
K972723 · HCC
Mindmedia Labs, Inc.
Neurology · 73d
Cleared Oct 02, 1997
GENESIS
K972871 · ELW
Pacific Rim Dental, Inc.
Dental · 59d
Cleared Oct 02, 1997
CAVIT-LC
K972892 · EBF
Espe GmbH & Co. Kg.
Dental · 58d
Cleared Oct 02, 1997
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047 · DIS
Drial Consultants, Inc.
Toxicology · 48d
Cleared Oct 02, 1997
AMSINO I.V. ADMINISTRATION SET
K973107 · FPA
Amsino Intl., Inc.
General Hospital · 44d
Cleared Oct 01, 1997
PERACT 20 LIQUID STERILANT
K960513 · MED
Minntech Corp.
General Hospital · 604d
Cleared Oct 01, 1997
LEIBINGER SELF-DRILLING SCREW
K970912 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 203d
Cleared Oct 01, 1997
OXI-SNAP
K971184 · MNR
Snap Laboratories, LLC
Anesthesiology · 183d
Cleared Oct 01, 1997
DISTALLY FIXED HIP STEM
K971523 · MEH
Sulzer Orthopedics, Inc.
Orthopedic · 156d
Cleared Oct 01, 1997
COLORPOINT OR PROFESSIONAL COLORPOINT
K971760 · LMC
Seiko Instruments USA, Inc.
Radiology · 142d
Cleared Oct 01, 1997
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND...
K971935 · JBP
B & D Corp.
Hematology · 127d
Cleared Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · HWC
Depuy, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
K972506 · HJM
Infinitech, Inc.
Ophthalmic · 90d
Cleared Oct 01, 1997
NAVIGATOR (STYLET) 2006
K972521 · GAH
Sil-Med Corp.
General & Plastic Surgery · 86d
Cleared Oct 01, 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 86d
Cleared Oct 01, 1997
HEARTPORT INTRODUCER SHEATH
K972570 · DYB
Heartport, Inc.
Cardiovascular · 83d
Cleared Oct 01, 1997
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K972578 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 83d
Cleared Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE...
K972579 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Oct 01, 1997
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · ERL
Stryker Endoscopy
Ear, Nose, Throat · 83d