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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96673–96696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1996
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
K963085 · JJX
International Enzymes, Inc.
Chemistry · 12d
Cleared Aug 20, 1996
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
K963116 · JMO
Diagnostic Chemicals , Ltd.
Chemistry · 8d
Cleared Aug 19, 1996
CROSS-CHECKS
K951113 · LRT
Steritec Products Mfg Co, Inc.
General Hospital · 528d
Cleared Aug 19, 1996
OMICRON MONITOR, DELTA MONITOR
K960861 · CBK
Core-M, Inc.
Anesthesiology · 171d
Cleared Aug 19, 1996
INTERFERENCE SCREW
K960962 · HWC
Linvatec Corp.
Orthopedic · 161d
Cleared Aug 19, 1996
PHILIPS MULTIDIAGNOST 4
K961374 · OWB
Philips Medical Systems, Inc.
Radiology · 132d
Cleared Aug 19, 1996
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573 · CIN
Hybritech, Inc.
Chemistry · 118d
Cleared Aug 19, 1996
PR-3 ELISA TEST SYSTEM
K961764 · MOB
Immunoprobe, Inc.
Immunology · 104d
Cleared Aug 19, 1996
MPO ELISA TEST SYSTEM
K961765 · MOB
Immunoprobe, Inc.
Immunology · 104d
Cleared Aug 19, 1996
QUALITROL CRP CONTROL SET
K961829 · DCK
Consolidated Technologies, Inc.
Immunology · 98d
Cleared Aug 19, 1996
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
K962069 · LYZ
Medline Industries, Inc.
General Hospital · 83d
Cleared Aug 19, 1996
ZWEYMUELLER SL FEMORAL HIP STEM
K962101 · LZO
Intermedics Orthopedics
Orthopedic · 81d
Cleared Aug 19, 1996
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186 · LBR
Genzyme Corp.
Chemistry · 74d
Cleared Aug 19, 1996
PRO-FECT STERILE GAUZE SPONGES
K962227 · EFQ
Network Trading Corp. Dba Grand Intl.
General & Plastic Surgery · 70d
Cleared Aug 19, 1996
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 68d
Cleared Aug 19, 1996
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353 · DIO
Princeton BioMeditech Corp.
Toxicology · 62d
Cleared Aug 19, 1996
UROTAC BONE ANCHOR INSERTER
K962372 · HXJ
Influence, Inc.
Orthopedic · 61d
Cleared Aug 19, 1996
RADWORKS MEDICAL IMAGING SOFTWARE
K962699 · LMD
Applicare Medical Imaging, B.V.
Radiology · 39d
Cleared Aug 19, 1996
ILIZAROV EXTERNAL FIXATION SYSTEM
K962808 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 32d
Cleared Aug 16, 1996
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · LGD
Abbott Laboratories
Microbiology · 319d
Cleared Aug 16, 1996
SAFESTRIP
K955107 · CGA
Firehouse Medical, Inc.
Chemistry · 282d
Cleared Aug 16, 1996
PATIENT MONITOR MODEL 405P
K955546 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 255d
Cleared Aug 16, 1996
RADIAS PHENYLALANINE TEST
K960437 · JNB
Bio-Rad
Chemistry · 198d
Cleared Aug 16, 1996
PROSPORE II
K960790 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 172d