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
151321–151344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1984
RD CELLS
K843251 · KIR
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 06, 1984
AFRICAN GREEN SV 5/SV 40
K843252 · KIR
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 05, 1984
COMBION SKIN TEST - FOUR PRONG
K833999 · SCL
Nicholas H. Maganias
General Hospital · 289d
Cleared Sep 05, 1984
CK10000 SERIES POUCH & BAGS ETC.
K834558 · KCT
Currie Medical Specialties, Inc.
General Hospital · 252d
Cleared Sep 05, 1984
COLOTRAK OCCULT BLOOD TEST
K840527 · KHE
Breit Laboratories, Inc.
Hematology · 211d
Cleared Sep 05, 1984
AUTOLYZER 800
K841852 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 125d
Cleared Sep 05, 1984
DOSE RELEASE OF STERILIZATION LOTS
K841949 · FMF
Medcare Disp Products, Inc.
General Hospital · 114d
Cleared Sep 05, 1984
COMBO SKIN TEST READY TO USE TAPE
K842107 · SCL
Combion Systems, Inc.
General Hospital · 99d
Cleared Sep 05, 1984
OCCULT BLOOD TEST
K842137 · KHE
Breit Laboratories, Inc.
Hematology · 98d
Cleared Sep 05, 1984
DISPOSABLE STOPCOCKS
K842173 · FMG
Procedure Products, Inc.
General Hospital · 113d
Cleared Sep 05, 1984
AMIZYME-SCHISTOSOMA SPP. TEST KIT
K842527 · GNH
Amico Lab, Inc.
Microbiology · 69d
Cleared Sep 05, 1984
CUSTOM CANAL HEARING AID X-CITE 84
K842546 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 05, 1984
OMED DISPOS. INSTRUMENT GUARDS
K842603
Omega-Med Intl., Inc.
General & Plastic Surgery · 62d
Cleared Sep 05, 1984
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT
K842692 · JHI
Quidel Corp.
Chemistry · 56d
Cleared Sep 05, 1984
EMIT D.A.U. LOW & MED. CALIBRATORS B
K842816 · DKB
Syva Co.
Toxicology · 49d
Cleared Sep 05, 1984
CALCITONIN RADIOIMMUNOASSAY KIT
K842907 · JKR
Nichols Institute Diagnostics
Chemistry · 43d
Cleared Sep 05, 1984
AMERLEX-M FREE T-3 RIA
K842949 · CDP
Amersham Corp.
Chemistry · 61d
Cleared Sep 05, 1984
IN-THE-EAR-CANAL HEARING AID
K842980 · ESD
Ear Care Hearing Systems, Inc.
Ear, Nose, Throat · 37d
Cleared Sep 05, 1984
DISPOSABLE LAPAROTOMY SPONGE
K843037
Anago, Inc.
General & Plastic Surgery · 34d
Cleared Sep 05, 1984
TCA HEARING AID
K843067 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 05, 1984
UTILITY SCISSORS DISPOSABLE ITEMS
K843075 · JOK
Greene International Corp.
General Hospital · 30d
Cleared Sep 05, 1984
CORMED HUBER POINT NEEDLE
K843083 · GAA
Cormed, Inc., Sub. C.R.Bard, Inc.
General & Plastic Surgery · 30d
Cleared Sep 05, 1984
APR MOBILE
K843192 · IZL
Philips Medical Systems (Cleveland),...
Radiology · 22d
Cleared Sep 05, 1984
CLINITRON AIR FLUIDIZED SUPPORT J-101UD
K843389 · INX
Uhi Corp.
Physical Medicine · 7d