FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133777–133800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1988
E.T. PUFFER
K884374 · BZA
Kalajian Ent.
Anesthesiology · 36d
Cleared Nov 23, 1988
PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR
K884541 · IPL
Pro-Vertic, Inc.
Physical Medicine · 23d
Cleared Nov 23, 1988
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · BSK
Instrumentation Industries, Inc.
Anesthesiology · 16d
Cleared Nov 22, 1988
GHB SAMPLE PAPER
K880673 · LCP
Isolab, Inc.
Hematology · 277d
Cleared Nov 22, 1988
ACCUTEMP PLUS
K881670 · FMT
Sentry Medical Products, Inc.
General Hospital · 218d
Cleared Nov 22, 1988
NEEDLE EJECTOR
K881867 · FMF
Howard, Hills & Harsh
General Hospital · 203d
Cleared Nov 22, 1988
LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
K883212 · KXA
Implant Technology, Inc.
Orthopedic · 116d
Cleared Nov 22, 1988
TENSIOMETER
K883694 · LXH
W.L. Gore & Associates, Inc.
Orthopedic · 85d
Cleared Nov 22, 1988
MSI-CAL 7
K883703 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309
K883822 · HMP
Consolidated Industries of Greater...
General & Plastic Surgery · 76d
Cleared Nov 22, 1988
MSI-CAL 16
K883850 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
MSI-CAL 8
K883851 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191 · GNX
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · LKT
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
K884193 · GQS
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
K884194 · GQS
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
TECHNICON RA-PHENOBARBITAL
K884419 · DLZ
Technicon Instruments Corp.
Toxicology · 33d
Cleared Nov 22, 1988
MODIFICATION MIC/API UNISCEPT(R)
K884509 · JWY
Analytical Products, Inc.
Microbiology · 26d
Cleared Nov 22, 1988
MODIFICATION MICRO-MIC
K884510 · JWY
Analytical Products, Inc.
Microbiology · 26d
Cleared Nov 22, 1988
RPMI-1640 HYBRI-MAX, PROD. NO. R5382
K884572 · KIT
Sigma Chemical Co.
Pathology · 21d
Cleared Nov 22, 1988
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891
K884573 · KIT
Sigma Chemical Co.
Pathology · 21d
Cleared Nov 22, 1988
DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785
K884574 · KIT
Sigma Chemical Co.
Pathology · 21d
Cleared Nov 22, 1988
MODIFIED SLIDING RECONSTITUTION DEVICE
K884626 · LHI
Baxter Healthcare Corp
General Hospital · 15d
Cleared Nov 22, 1988
MULTI-PURPOSE HOLDER
K884630 · LDQ
Med-Dex Intl.
General & Plastic Surgery · 15d