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
137521–137544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1987
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER
K874155 · KRC
Circadian, Inc.
Cardiovascular · 41d
Cleared Nov 23, 1987
PATIENT TEMPERATURE MONITOR, MODEL 1000
K874159 · FLL
Sonodyne America, Ltd.
General Hospital · 41d
Cleared Nov 23, 1987
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163 · CIX
Catachem, Inc.
Chemistry · 41d
Cleared Nov 23, 1987
S3 MEDICATED GAUZE
K874219 · FRO
Surgical Specialties, Inc.
General & Plastic Surgery · 38d
Cleared Nov 23, 1987
PRECINORM L
K874230 · JJY
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Nov 23, 1987
IRON HORSE ONE
K874246 · IOR
Iron Horse Productions, Inc.
Physical Medicine · 38d
Cleared Nov 23, 1987
VENTRESCREEN, HCG URINE
K874258 · JHI
Ventrex Laboratories, Inc.
Chemistry · 34d
Cleared Nov 23, 1987
WAKO(TM) FE C
K874263 · JIY
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Nov 23, 1987
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
K874299 · CEW
Incstar Corp.
Chemistry · 34d
Cleared Nov 23, 1987
SKIN PREP ANALYZER
K874327 · KRC
Marquette Electronics, Inc.
Cardiovascular · 33d
Cleared Nov 23, 1987
TUMORIMETER
K874352 · FTY
Cancer Technologies, Inc.
General & Plastic Surgery · 31d
Cleared Nov 23, 1987
PIN PUNCH
K874356 · LRY
Med-Tool, Inc.
General & Plastic Surgery · 31d
Cleared Nov 23, 1987
TAPERED PUNCH
K874357 · LRY
Med-Tool, Inc.
General & Plastic Surgery · 31d
Cleared Nov 23, 1987
COMBINATION WRENCHES
K874358 · HXC
Med-Tool, Inc.
Orthopedic · 31d
Cleared Nov 23, 1987
ADJUSTABLE WRENCHES
K874359 · HXC
Med-Tool, Inc.
Orthopedic · 31d
Cleared Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376 · JXM
Syva Co.
Toxicology · 28d
Cleared Nov 23, 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · DXY
Intermedics, Inc.
Cardiovascular · 26d
Cleared Nov 23, 1987
BICARBONATE
K874435 · KHS
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Nov 23, 1987
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
K874477 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BARBITURATES
K874483 · DIS
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · LCL
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR OPIATES
K874485 · DJG
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · DKZ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · DIO
Abbott Laboratories
Toxicology · 24d