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
153769–153792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1984
BIOSONICS SALIVARY TESTER
K833635
Meyer, Faller & Weisman
Dental · 133d
Cleared Feb 27, 1984
HYDROXYLINE
K833640 · EJK
George Taub Products & Fusion Co., Inc.
Dental · 133d
Cleared Feb 27, 1984
TITAN GEL SILVER STAIN SYSTEM
K833855 · CEF
Helena Laboratories
Pathology · 112d
Cleared Feb 27, 1984
MENISCAL SUTURING SYSTEM
K833943 · LXH
Dyonics, Inc.
Orthopedic · 104d
Cleared Feb 27, 1984
MODEL XLE
K834087 · IYO
Interad Systems, Inc.
Radiology · 166d
Cleared Feb 27, 1984
VACUUM REGULATOR 0-2000 MMHG VR-1000
K834224 · KDP
Trimeter Instrument Corp.
General Hospital · 83d
Cleared Feb 27, 1984
PBC EXTENSION SET
K834252 · FPA
Philadelphia Biologics Center
General Hospital · 82d
Cleared Feb 27, 1984
PBC IV SET NON-VENTED
K834253 · FPA
Philadelphia Biologics Center
General Hospital · 82d
Cleared Feb 27, 1984
PBC IV SET VENTED
K834254 · FPA
Philadelphia Biologics Center
General Hospital · 82d
Cleared Feb 27, 1984
MYCOPLASMA PNEUMONIAE CF ANTIGEN
K834338 · GSB
Hillcrest Biologicals
Microbiology · 77d
Cleared Feb 27, 1984
ENDIX RADICULAR BIOCERAMIC PIN
K834363 · ELS
C.B.S. Biotechnics, Inc.
Dental · 123d
Cleared Feb 27, 1984
SURGICAL INSTRUMENTS & ACCESSORIES
K834366 · EMH
C.B.S. Biotechnics, Inc.
Dental · 123d
Cleared Feb 27, 1984
CRANE MENISCAL SUTURE SET
K834369 · LXH
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared Feb 27, 1984
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER
K834370 · LXH
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared Feb 27, 1984
DENTURE BASE RESIN
K834409 · EBI
Dentsply Intl.
Dental · 75d
Cleared Feb 27, 1984
CK-NAC REAGENT
K834502 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Feb 27, 1984
DISCRETE CLINICAL ANALYZER
K834521 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 68d
Cleared Feb 27, 1984
VITEX P.D.A
K834560 · EJH
Jeneric Ind.
Dental · 61d
Cleared Feb 27, 1984
NABI CRP-Q.S. TEST
K834584 · DCN
Intl. Diagnostic, Inc.
Immunology · 60d
Cleared Feb 27, 1984
WILCOR-XR RP-OG MEDICAL FILM
K834612 · IWZ
Cea America Corp.
Radiology · 69d
Cleared Feb 27, 1984
INDIRECT FLUORESCENT ANTIBODY MYCO
K840012 · GRZ
Zeus Technologies
Microbiology · 54d
Cleared Feb 27, 1984
VACUUM STRETCHER IMMOBILIZER
K840034 · FPP
Medicon, Inc.
General Hospital · 53d
Cleared Feb 27, 1984
TOTAL HIP FEMORAL COMPONENT
K840150 · JDI
Advanced Biosearch Assn.
Orthopedic · 45d
Cleared Feb 27, 1984
EPIDURAL CATHETER
K840202 · BSO
Aries Medical, Inc.
Anesthesiology · 39d