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
107545–107568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1994
SPECIMEN REMOVAL DEVICE
K941249 · GCJ
General Surgical Innovations
General & Plastic Surgery · 114d
Cleared Jul 07, 1994
UNILENS 38 SOFT ASPHERIC CONTACT LENS
K941836 · LPL
Unilens Corp., USA
Ophthalmic · 85d
Cleared Jul 07, 1994
VASCU-GUARD
K942010 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 73d
Cleared Jul 07, 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205 · KNY
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Jul 07, 1994
SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS
K942372 · LPL
Unilens Corp., USA
Ophthalmic · 50d
Cleared Jul 07, 1994
ORIGIN BALLOON RETRACTOR
K942491 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 43d
Cleared Jul 07, 1994
BIOPSY NEEDLE AND HOUSING
K942639 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 07, 1994
SURGIN IRRIGATION PUMP
K942641 · GCJ
Surgin Surgical Instrumentation, Inc.
General & Plastic Surgery · 34d
Cleared Jul 06, 1994
ALICE
K922106 · OLV
Healthdyne, Inc.
Neurology · 792d
Cleared Jul 06, 1994
DSL IGFBP-3 RIA (DSL 6700)
K930047 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 547d
Cleared Jul 06, 1994
AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
K932093 · CAC
Boehringer Laboratories
Anesthesiology · 432d
Cleared Jul 06, 1994
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
K932892 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 387d
Cleared Jul 06, 1994
BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
K934293 · JFJ
Beckman-Diagnostic Systems Group
Chemistry · 307d
Cleared Jul 06, 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · LZO
Depuy, Inc.
Orthopedic · 296d
Cleared Jul 06, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS
K934498 · DIF
Medical Analysis Systems, Inc.
Chemistry · 294d
Cleared Jul 06, 1994
OMNI-CENTRAL STATION MONITOR
K936051 · DRT
Invivo Research, Inc.
Cardiovascular · 198d
Cleared Jul 06, 1994
STREP B OIA
K936112 · GTY
Biostar, Inc.
Microbiology · 195d
Cleared Jul 06, 1994
MODEL#1550 MARSONA(R) TINNITUS MASKER
K940567 · KLW
Marpac, Inc.
Ear, Nose, Throat · 148d
Cleared Jul 06, 1994
ORBSCAN(TM) KERATOMETER
K940647 · HLQ
Orbtek, Inc.
Ophthalmic · 141d
Cleared Jul 06, 1994
URINE CALIBRATOR
K940935 · DKB
Diagnostic Reagents, Inc.
Toxicology · 131d
Cleared Jul 06, 1994
PREGNANCY CHECK
K941355 · LCX
Sa Scientific, Inc.
Chemistry · 107d
Cleared Jul 06, 1994
EXACTA PERCUTANEOUS INTRODUCER SHEATH
K941428 · DYB
Ohmeda Medical
Cardiovascular · 104d
Cleared Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · LBZ
Roche Diagnostic Systems, Inc.
Toxicology · 104d
Cleared Jul 06, 1994
CREATINE KINASE METHOD
K941584 · JHS
Dupont Medical Products
Chemistry · 96d