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
144913–144936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1986
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · JLS
Immuchem Corp.
Chemistry · 144d
Cleared Feb 28, 1986
FASTENS(TM)
K854316 · GZJ
Medical Devices, Inc.
Neurology · 123d
Cleared Feb 28, 1986
WEP 7604 TELEMETRY MONITOR
K854369 · DXH
Nihon Kohden America, Inc.
Cardiovascular · 122d
Cleared Feb 28, 1986
VM 781 SLAVE SCOPE
K854372 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 122d
Cleared Feb 28, 1986
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482 · DXY
Medtronic Vascular
Cardiovascular · 113d
Cleared Feb 28, 1986
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
K854581 · EOQ
Machida America, Inc.
Ear, Nose, Throat · 105d
Cleared Feb 28, 1986
COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B
K854626 · BZC
Compumed, Inc.
Anesthesiology · 102d
Cleared Feb 28, 1986
2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE
K854743 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 95d
Cleared Feb 28, 1986
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 94d
Cleared Feb 28, 1986
INSTAPURE
K854817 · FRF
Teledyne, Inc.
General Hospital · 87d
Cleared Feb 28, 1986
MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
K854887 · EMH
Walter Lorenz Surgical, Inc.
Dental · 84d
Cleared Feb 28, 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · DFT
Kallestad Laboratories, Inc.
Immunology · 74d
Cleared Feb 28, 1986
COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
K855022 · BSZ
Computerized Anesthesia Systems, Inc.
Anesthesiology · 74d
Cleared Feb 28, 1986
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
K855065 · FPB
Cobe Laboratories, Inc.
General Hospital · 72d
Cleared Feb 28, 1986
DELFIA TM HLH KIT
K855173 · CEP
Lkb Instruments, Inc.
Chemistry · 64d
Cleared Feb 28, 1986
STIMUPLEX, NERVE STIMULATOR
K860126 · BXN
Burron Medical Products, Inc.
Anesthesiology · 45d
Cleared Feb 28, 1986
CARBON DIOXIDE ABSORBENTS
K860147 · CBL
Dentsply Intl.
Anesthesiology · 44d
Cleared Feb 28, 1986
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
K860228 · CFL
Boots-Celltech Diagnostics, Inc.
Chemistry · 37d
Cleared Feb 28, 1986
DUPONT PHENOBARBITAL CALIBRATOR
K860303 · LFN
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Feb 28, 1986
DUPONT PHENOBARBITAL ASSAY
K860304 · LFN
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Feb 28, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · CFH
Sterling Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 28, 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530 · CJA
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Feb 27, 1986
KALMATE MODEL 3A
K854476 · GZJ
Medical Technology Systems, Inc.
Neurology · 112d
Cleared Feb 27, 1986
BIO-FIT HIP SYSTEM
K854791 · KWL
Richards Medical Co., Inc.
Orthopedic · 90d